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CREATE-YOUR-OWNCONFERENCEChoose From 30+ Interactive Sessionsand In-Depth Workshops:• Validating Rapid Microbiology Methods• Real-Time Optical Sensors• Water Activity for Reduced Microbial Testing• Environmental Monitoring • Molecular Methods • Rapid Microbiological Methods• Preparing for an Audit• Microbiological Control in Manufacturing • Rapid Microbiological Testing• Microbial Enumeration Methods for Water• Non-sterile Manufacturing Environment• Microbial Bioburden Monitoring and Control• Water System Validation• Environmental Program for Non Aseptic

Manufacturing• Quality Agreements • Isolators for Sterility Testing• Methods for Purified Water Analysis• Microbiology Training Programs • Biological Indicators• Microbial Excursions and Investigations in Water

Systems• Method Development for Non-sterile

Pharmaceuticals• Polyphasic Approach to Microbial Identification• Trends in Aseptic Process Simulations• Air Monitoring• Electronic EM Data Management System• Identification of Filamentous Fungi• Microbial Limits Test• Microbial Identification Methods• Validation of Microbiological Test Methods

And Don’t Miss the:• Group Excursion• Networking Reception

FEATURED COMPANIES INCLUDE:

• Accugenix, Inc. • AES - Chemunex Inc. • Astrazeneca LP • BASF Corporation • Biolog •• BioVigilant • Compliance Software Solutions Corporation •

• Compliance, Advice and Services in Microbiology • Decagon Devices, Inc. •• Diosynth Biotechnology • Edgington Associates, Netherlands •

• European Pharmacopoeia • Genomic Profiling Systems • Japanese Pharmacopoeia •• JM Hansen and Associates • Leiner Health Products • Luitpold Pharmaceuticals • MIDI Inc. •

• Merck and Company • Monza Operations, Patheon Italia • National Institute Infectious Diseases •• Natural Alternatives International • Orchid Chemicals and Pharmaceuticals Ltd. • P 3 Scientific •

• Paddison Associates • Pall Life Sciences • Perritt Laboratories, Inc. •• Pharma Institute of GMPs, India • Ranbaxy Labs.Ltd.India •

• Schering Plough • Soli PharmaSolutions • United States Pharmacopeia •• Validation Technologies, Inc. • Vectech Pharmaceutical Consultants, Inc. • Wyeth •

2 FOCUS GROUP SESSIONSSTERILIZATION APPLICATIONS FOCUS:Applications of Sterilization Science toPharmaceutical Manufacturing

SPECIAL PHARMACOPEIA FOCUS:Current Activities of United States Pharmacopeia,European Pharmacopoeia and JapanesePharmacopoeia

CONFERENCE CO-CHAIRPERSONS:

Microbiology Event of the YearFor Pharmaceutical,Biotechnology & Medical Device Operations

June 20-23, 2006 • Washington, D.C. • Hamilton Crowne Plaza

Evening Awards Dinner for the

MICROBIOLOGIST OF THE YEAR 2006!Enter nominations now atwww.ivthome.com/nominateSee back cover for more information.

Dr. Jeanne MoldenhauerVectech Pharmaceutical Consultants, Inc.

Lucia ClontzDiosynth Biotechnology &

PLUS:

Tuesday, June 20, 20067:30 AM – Registration and Breakfast

Workshop 8:30 AM – 12:00 PMUnderstanding and Implementing Validation ofRapid Microbiological Methods Maitry Ganatra, Ph.D., Rapid Microbiology Specialist, Pall Life Sciences

I. Overview of Validation Requirements for RapidMicrobiology Methods

• Global regulatory trends • Key validation parameters • Developing validation strategy

II. Detailed Review of Validation GuidelineDocuments

• PDA Technical Report 33 Evaluation, Validation andImplementation of New Microbiological Testing Methods

• USP <1223> Validation of Alternative Microbiological Methods • EP 5.1.6 Alternative Methods for Control of Microbiological

Quality III. Implementation of Rapid Methods

• Differences between USP and EP guidance documents • Challenges in validation of rapid methods• Comparability protocols for traditional versus new methods

IV. Interactive Exercise A rapid microbiology method validation case study will be pre-sented. Attendees will have an opportunity to participate ininteractive discussion on practical experience

Workshop 8:30 AM – 12:00 PMReal-Time Optical Sensors for Microbial andEnvironmental MonitoringJ.P. Jiang, Chief Technology Officer, BioVigilant Laboratories

I. Overview of Optical Technologies for MicrobialDetection

• Optical and spectral methods used to detect microbes• Sensor technologies for bio-agent detections in Homeland

Security• The role of optical instruments in environmental monitoring• The relative merits of different optical technologies

II. How to Use Optical Technologies for Real-timeMicrobial Monitoring

• Mie scattering optical sensors for particle sizing and counting• Using intrinsic fluorescence as a biological marker• The concept of combined optical techniques for real-time and

continuous environmental microbial detection• Data display of detection results • Interpreting the data

III. Obtaining Trending Data from InstantaneousMicrobial Detection • Technical description of Instantaneous Microbial Detector• How to obtain histogram of optical detection data• Time-resolved histogram of environmental monitoring data • Using time-resolved histogram to obtain trending data• Evaluating trending data

IV. Process of Validating Instantaneous MicrobialDetection

• Identifying what Instantaneous Microbial Detector provides• Comparing results to conventional methods• Suggestions on how to validate this technology

V. Interactive ExerciseA demonstration of Instantaneous Microbial Detector will beprovided, and the audience will participate in the operation ofthe instrument and review of the data.

VI. Participants Will Take Home the Following Bonus Information

• Examples of the data and a White Paper on the technology

Workshop 8:30 AM – 12:00 PMUnderstanding Water Activity for Reduced MicrobialTesting Using USP Method <1112>Anthony J.Fontana Jr., Ph.D., Senior Research Scientist, Decagon Devices, Inc.

I. Water Activity Definition• Scientific derivation of water activity• Thermodynamic requirements for water activity• Factors in a product control water activity• Examples of water binding effect of different humectants

II. Water Activity vs. Moisture Content• Differences between water activity and moisture content

III. Water Activity Measurement• Different water activity measurement methods• Making accurate water activity measurement• Instrument validation and calibration

IV. Water Activity for Microbial Growth Limits• The importance of water activity in controlling microbial

growth• Low water activity products and microbial contamination• Understanding USP Method <1112> Microbiological

Attributes of Non-sterile Pharmaceutical Products.• Making preservative-free formulations using a hurdles

approach to control water activityV. Other Pharmaceutical Uses for Water Activity

• Water activity in pharmaceutical formulation, manufacturing,and storage

• Controlling, screening, and predicting physical stabilitychanges

• Degradative chemical reactions in products• Predicting moisture transfer in pre-formulation compatibility

studies

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Tuesday, June 20, 2006Pre-Conference Half-Day Workshops


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Workshop 8:30 AM – 12:00 PMStrategies for Establishing a CompliantEnvironmental Monitoring Program; ImplementingEU and FDA Regulatory Requirements Michael Dolan, Senior Environmental Monitoring Analyst,

Merck and Company

Jason J.O’Hare, BS Microbiology, Senior QC Microbiologist,formerly with Genzyme Corporation

David Vincent,CEO,Validation Technologies, Inc.

I. Environmental Monitoring: the U.S. Perspective• The FDA’s new aseptic guidance• Environmental monitoring policies, SOPs, and protocols• Regulatory expectation for EM programs• Managing, tracking, and trending EM data• Developing EM performance qualification protocols• Instrumentation and sampling methods limitations• Establishing action and alert limits• Managing and investigation of out-of-action limits (OALs)• Determining cleanrooms classification• Implementing the new ISO standards for cleanrooms• Cleaning and disinfecting for cleanroom environments

II. Environmental Monitoring: The EuropeanPerspective

• Comparison between U.S. and EU regulatory requirements• EU-GMP Annex 1: viable and non viable monitoring

requirements• Setting and managing action/alert levels• Action/alert levels excursions: investigations and effective

corrective actions• Microbial identification in an EM program• Qualification of cleaning and disinfection SOPs• EUGMP - based inspections

III. Use of VHP for Large Room DecontaminationsIV. Interactive Exercises

• Handling an Environmental Monitoring InvestigationThe attendees will form into groups and formulate a rootcause to an excursion. This exercise will illustrate how different perspectives and interpretations can lead an investigation in various paths.

• Writing an Effective Standard Operating ProcedureAttendees break into groups to write steps for a procedure.This exercise will convey Lab SOPs and demonstrate theimportance of collaboration, clear writing style, knowing one's audience and relate to CFRs.

Workshop 8:30 AM – 12:00 PMIdentification and Characterization ofMicroorganisms Using Molecular MethodsMichael Waddington, VP, Operations, Accugenix, Inc.

I. Overview of Comparative DNA Sequencing• An accurate and reproducible methodology

II. Regulatory Focus• FDA recommends this technology in certain circumstances to

ensure correct identifications

III. Microbial Phylogeny• Genetic relatedness• Comparison and tree drawing algorithms

IV. Interpretation of DNA Sequence Data• Identifying unknown organisms• Comparing genetic distances

V. Trending and Tracking of DNA Sequence Data• Using genetic information to track unidentified organisms• Comparing methodologies

12:00 PM – Luncheon for Workshop Attendees A – E

Special Pharmacopeia Focus: Current Activities 1:00 PMUnited States Pharmacopeia, EuropeanPharmacopoeia and Japanese PharmacopoeiaRadhakrishna Tirumalai, Ph.D., Liaison to the Microbiology and

Sterility Assurance Expert Committee, United States Pharmacopeia(Invited Speaker)

Dr. Klaus Haberer, Managing Director, Compliance, Advice andServices in Microbiology, European Pharmacopoeia

Tsuguo Sasaki, Ph.D., Chief of Department of Bacteriology II, NationalInstitute of Infectious Diseases, Japanese Pharmacopoeia

Experts from the USP, Ph Eur, and JP will discuss the status ofInternational Harmonization of Tests and Criteria for Non-SterilePharmaceutical Products.

The harmonized methods for Microbiological Examination ofNon-Sterile Products,Test for Specified Microorganisms, and theMicrobiological Attributes of Non-Sterile PharmacopoeialArticles have been signed off by the Pharmacopoeial DiscussionGroup (PDG.) The differences of the harmonized proceduresand criteria to the existing tests and the process of implementa-tion will be highlighted.

• USP <61> Microbial Limits Tests • USP <1111> Microbiological Attributes of Non-Sterile

Pharmacopoeial ArticlesAlso, there will be a brief overview of the newly approvedMicrobiology General Chapters in the USP.

• <1072> Disinfectants and Antiseptics• <1112> Application of Water Activity Determination to

Nonsterile Pharmaceutical Products • <1117> Microbiological Best Laboratory Practices• <1223> Validation of Alternative Microbiological Methods• Comparison of JP microbiological chapters with those of the

USP/EP.• Future plans for JP microbiological chapters.

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Tuesday, June 20, 2006Main Conference General Sessions

2:15 PMLate-Breaking Developments from the USPPharmaceutical Water Expert CommitteeTeri C. (“T.C.”) Soli, Ph.D., Consultant, Soli Pharma Solutions, Inc.Member of USP Pharmaceutical Water Expert Committee for 2000-2005and 2005-2010

This session will address the recent developments related to waterwithin USP; in particular, the newly revised <1231> “Water forPharmaceutical Purposes,” the new monograph for Pure Steam,recent changes to how the WFI monograph now says it can be produced, as well as ongoing and upcoming committee initiatives.In addition, the ever-changing structure of the USP organization as well as its compendium will also be covered.

• Who and what is USP and how do they get stuff done?• Mandatory vs. non-mandatory• FDA use (or misuse) of USP• Discussing the most recent developments related to water that

are now in effect• What ongoing and new water issues are the newly appointed

PWEC members working on?

3:00 PM – Refreshment Break

3:15 PMComparison of Compendial Requirements for theDetection of Mycoplasma Contamination from CellCulturesTsuguo Sasaki, Ph.D., Chief of Department of Bacteriology II, NationalInstitute of Infectious Diseases

Mycoplasma is one of the major contaminants in cell cultures. Asreferring to some compendial requirements for the detection ofmycoplasma contaminants from cell cultures, such as EP/JP, WHOrequirement, VICH, CFR, etc., culture methods, indicator cell culturemethod, and PCR methods were compared.This session will propose the most practical and reliable methods to detectmycoplasmas in cell cultures.

• Culture method: how to get good quality of media componentssuch as basal medium, horse serum, fresh yeast extract?

• Indicator cell culture method:What kind of mycoplasmal strainsare suitable for the validation of the cell substrate?

• PCR method: to date, many PCR primers have been developed byvarious investigators for the detection of mycoplasmal contami-nation of cell cultures. Among them, which PCR primers are themost reliable to detect mycoplasmas in cell cultures from the sen-sitivity and specificity?

4:00 PMBacterial Endotoxins and Their InactivationSumant Baukhandi, Ph.D., Director, Pharma Institute of GMPs, India

President – Regulatory Affairs & Quality Affairs, Orchid Chemicals &Pharmaceuticals Ltd., India

This session will address the bacterial endotoxins in general fol-lowed by its importance in the pharmaceutical industry. It will coverinactivation of bacterial endotoxins in pharmaceutical processes inparticular. Both thermal and non thermal inactivation processes willbe discussed.The latter part will touch upon validation of depyro-genation process.

• Overview of bacterial endotoxins• Contamination of pharmaceutical processes with endotoxins• Thermal inactivation of bacterial endotoxins• Non-thermal inactivation of bacterial endotoxins• Development of validation cycle for depyrogenation

4:45 PMGetting a Rapid Sterility Test Approved - Case StudiesJeanne Moldenhauer, Pharma Consultant, Vectech PharmaceuticalConsultants, Inc.

For many years, the rapid sterility test has been the "golden calf" forpharmaceutical companies to pursue in their desire to implementrapid microbiological methods.This talk will provide an overview ofan approach successfully used in obtaining approval of a rapidsterility test method.

• Identification approaches used for rapid sterility testing• Issues in validating these methods• Identification of associated risks and benefits of these methods

6:00 PM – 7:00 PM – Networking Cocktail ReceptionSponsored by


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Wednesday, June 21, 2006Schedule of Events

2:00 PM GROUP EXCURSION:Take pleasure in browsing the exhibits of the SmithsonianNational Museum of Natural History and an IMAX filmscreening of Aliens of the Deep (3D).The group will meetin the hotel lobby at 2:00 PM and walk to theSmithsonian National Museum of Natural History.Behold displays on marine science in the Ocean Hall orobserve Frost: Life and Culture of the Sámi. At 3:25 PM there will be anIMAX film screening of Aliens of the Deep (3D), which will reveal some of thestrangest animals under the sea. The screening will run just under an hour andonce it concludes group members may continue enjoying exhibits until themuseum closes or they may begin their leisurely walk back to the hotel andtake in some of the landmarks that make up Washington, D.C.

(All participants must check the box on the registration form to attend this excursion)

7:30 AM . . . . . . . . Breakfast

8:15 AM . . . . . . . . Sterilization Applications Begins

10:00 AM– 10:30 AM . . . . . . . Refreshment Break

12:30 PM . . . . . . . Sterilization Applications Concludes

2:00 PM . . . . . . . Group Excursion

6:30 PM . . . . . . . Cocktail Reception

7:30 PM . . . . . . . Awards Dinner and Keynote Speaker

9:00 PM . . . . . . . Conclusion


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Wednesday, June 21, 2006Sterilization Applications – Group Excursion – Awards Dinner

Sterilization Applications Focus Group Applications of Sterilization Science to Pharmaceutical Manufacturing

I. Biological Indicators as Measuring Tools: Uses,Precautions and LimitationsMargarita Gómez, Ph.D, Manager Technical Services,VPCI Inc.

Biological Indicators (BIs) are used in the development, vali-dation and monitoring of sterilization processes. As with anymeasuring tool, BIs should be calibrated and they shouldonly be used for their intended purpose. In this presentationan overview of the methods used to characterize the heatresistance of BIs will be presented as well as some com-ments on the proper selection, handling, and use of BIs.

• Reviewing general characteristics of BIs• Gaining knowledge regarding methods of characteriz-

ing the heat resistance of biological indicators• Understanding the factors that affect heat resistance• Understanding the relationship between resistance of

the bioburden and resistance of the BI

II. Highlights of the European SterilizationApproach

Dr. Klaus Haberer, Managing Director, Compliance,Advice and Services in Microbiology, Expert of the EP

The European approach towards sterilization of pharmaceu-tical products is fundamentally different from the approachtaken in the USA. Historical development, the strong influ-ence of hospital sterilization practice, and the orientationtowards technical standards result in a different view onmany points in the sterilization process. Among the contro-versial topics are:

• The European approach to steam sterilization, its merits,and pitfalls

• Comparing the European approach to the U.S. approach

III. EO/Radiation SterilizationJoyce Hansen, President, JM Hansen & Associates

(Session details unavailable for print. Please checkwww.ivthome.com for updates.)

IV. D-values and Cycle Design Jeanne Moldenhauer, Pharma Consultant, VectechPharmaceutical Consultants, Inc.

Among the differences between the U.S. and Europeanapproaches to steam sterilization, the concept of D-valuescan be one of the most difficult to understand.This talkdescribes the types of data required by FDA and how it isused in designing sterilization cycles.

• Learning what makes the D-value important to cycledesign

• How to handle higher D-values without eliminating terminal sterilization

• Understanding key submission expectations relative to D-values

V. Current USP Perspectives on TerminalSterilization and Parametric ReleaseRadhakrishna Tirumalai, Ph.D., Liaison to theMicrobiology and Sterility Assurance ExpertCommittee, USP (Invited Speaker)

Release of a sterile product, due to limitations in testing,cannot rely solely on a pharmacopeial sterility test. Releasespecifications for sterility (Probability of Nonsterility of 10-6)can be achieved either by terminal sterilization or asepticprocessing.With Prior Regulatory Approval, end productsterility testing of terminally sterilized articles can be substi-tuted by submission of well supported scientific rationale forthe terminal sterilization process and well documented vali-dation data (Parametric Release).

• Release Criteria• Exploring Terminal Sterilization• Parametric Release: Defining and Using this Method for

Sterilization Processes

VI. Principles of Steam-In-Place Sterilization (SIP)Sumant Baukhandi, Ph.D., Director, Pharma Instituteof GMPs, IndiaPresident – Regulatory Affairs & Quality Affairs,Orchid Chemicals & Pharmaceuticals Ltd., India

This session will address the various principles of Steam-In-Place (SIP) and its applicability in sterilization of aseptic pro-cessing equipment.It will discuss configuration of SIP systemsand its associated critical requirements such as proper steamdistribution,non-condensable gasses removal,and continuouscondensate elimination.It will also address Good EngineeringPractices,which are essential to ensure SIP validation.

• Significance of SIP systems• Automated SIP systems in providing assurance• Adequacy of sterilization by condensate removal• Current industry practice of SIP systems• Validation requirements of SIP systems

VII. Parametric Release for Moist-Heated Productsin Japan

Tsuguo Sasaki, Ph.D., Chief of Department ofBacteriology II, National Institute of InfectiousDiseases

Parametric release is defined as a declaration that a productis sterile, based on records demonstrating that the processparameters were delivered within specified tolerances.Different from the USP or EP, the JP is a legally authorizedpublication under the Pharmaceutical Affairs Law.This ses-sion will describe the current status of parametric release forterminally sterilized pharmaceutical products in Japan.

• Reviewing the policy on parametric release forterminally sterilized health care products in Japan

• Setting acceptance criteria for parametric release of terminally sterilized pharmaceutical products in Japan

• Future plan for parametric release in Japan

Enter nominations now atwww.ivthome.com/nominate

Hosting this year’s award ceremony will be Dr. Tony Cundell, Ph.D.,

Director, Pharmaceutical Sciences - Microbiology, Schering-Plough Research Institute.

Dr. Cundell was the honored recipient of IVT's MICROBIOLOGIST OF THE YEAR 2005.

Evening Awards Dinner for the

MICROBIOLOGIST OF THE YEAR 2006!

IVT's award program is designed to recognize and honor industry's most talented microbiology professionals. Join your fellow industry colleagues at this evening gala to welcome and congratulate this year's nominee for IVT'S MICROBIOLOGIST OF THE YEAR 2006 AWARD! A cocktail reception will begin the festivities followed by a sumptuous dinner and award ceremony. See back cover for more information and enter your nomination at www.ivthome.com/nominate.

During this session of the Microbiology Event of the Year, experts in sterilization and sterility assurance will discuss varioustechniques used in development, implementation, validation and on-going use of terminal and in-process sterilizationprocesses.This group is composed of personnel who have spent many years in the industry and are considered leaders insterilization sciences.

Margarita Gómez, Ph.D., Manager Technical Services,VectechPharmaceutical Consultants, Inc.

Dr.Klaus Haberer, Managing Director,Compliance,Advice andServices in Microbiology, Expert of the EP

Joyce Hansen,President, JM Hansen & Associates

Jeanne Moldenhauer,Pharma Consultant,Vectech PharmaceuticalConsultants, Inc.

Radhakrishna Tirumalai, Ph.D., Liaison to the Microbiology andSterility Assurance Expert Committee, USP Invited Speaker

Sumant Baukhandi, Ph.D., Director,Pharma Institute of GMPs,India President – Regulatory Affairs & Quality Affairs,OrchidChemicals & Pharmaceuticals Ltd., India

Tsuguo Sasaki, Ph.D., Chief of Department of Bacteriology II,National Institute of Infectious Diseases

7:30 AM – Breakfast

Workshop 8:30 AM – 12:00 PMValidating Microbial Enumeration Methods forWater: A Very Different Sort of BeastTeri C. (“T.C.”) Soli, Ph.D., Consultant, Soli Pharma Solutions, Inc.

Member of USP Pharmaceutical Water Expert Committee for 2000-2005and 2005-2010

I. Importance of the Water Microbial Count Method• Why FDA expects validation of this method• Why there is confusion over what that expectation means• How this method validation is different• The challenge organism dilemma• What to look for in a valid method for your water system• Same method may not be optimal for every water system

II. Why the Aquatic Biofilm Microbial MakeupImpacts Your Enumeration Method Options

• Oligotrophs, copiotrophs, and facultatives and preferred media• Water purity and system maintenance select for these populations• Understanding why some bacteria may be considered objec-

tionable and others aren’t• Types of bacteria recovered by other USP product tests• Which populations are important to enumerate and why• Possible test options and their vulnerabilities

III. Microbial Count Method, Process Control, andWater Quality

• Establishing meaningful alert and action levels• Why microbial speciation may or may not be important• Why USP is “officially” silent on these water issues

IV. Importance of Water System Design and SamplingTechnique?

• The impact of valves and hoses• Impact of insufficient outlet flushing and how much is enough• Identical flushing between production and sampling

V. Interactive ExerciseAttendees will be shown example sets of monitoring data usingvarious enumeration options and asked to evaluate the dataand select the best option for the intended purpose of themonitoring.


• A copy of the latest revision to <1231> from USP29 whichaddresses this subject and can be used as a reference.

Workshop 8:30 AM – 12:00 PMPreparing for an Audit of the QC MicrobiologyLaboratory in a Parenteral Drugs Production PlantDavid Vincent, CEO, Validation Technologies, Inc.

Francesco Boschi, QC Microbiology Manager, Monza Operations,Patheon Italia

I. cGMP in the Microbiology LaboratoryII. Laboratory Staff: Skills and Training Expectations

• Organization within the micro lab• Current expectations in terms of studies and experience• Keeping training tracked and updated

III. Laboratory Equipment• Preventive and corrective maintenance• Validation program• Environmental monitoring within testing areas

IV. Analytical Methods Qualification• Compendial requirements • Maintenance and control of bacterial strains• How to keep in qualified conditions

V. Standards and Analytical Materials• Incoming materials management• Testing incoming materials vs. supplier qualification• Media management: ready to use vs. in-house prepared

VI. Documentation Practices• Good documentation practices• Most common mistakes in test documentation• Use of automated documentation systems

VII. Laboratory Investigations• OOS Management• Environmental monitoring excursion management• Sterility test failures

VIII. Interactive ExerciseDeveloping a training program for micro analysts and supervisors. Attendees will develop specific training programsfor different job positions within a QC microbiology laboratory.

Workshop 8:30 AM – 12:00 PMMicrobiological Control in Pharmaceutical andBiotech Manufacturing Lucia Clontz, Director of Microbiology, Diosynth Biotechnology

I. Microbial Contamination • Discussing potential sources of contamination• Presenting current regulatory expectations and standards

II. Management of Contamination Control• Discussing typical microbial control measures• Factors for an effective cleaning or disinfection program • Factors for an effective environmental monitoring program

III. Risk Assessment Applied to ContaminationControl

• Presenting the use of HACCP in process risk assessments IV. Interactive Exercise

Case studies dealing with microbial contamination control willbe presented. Groups will be asked to apply the HACCP tool toa representative process unit operation.

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Thursday, June 22, 2006Half-Day Interactive Workshops

HOTEL INFORMATION

Hamilton Crowne Plaza14th and K Street, NW, Washington, DC 20005Tel: 800.263.9802 • Fax: 202.682.9525www.HamiltonDCHotel.com

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IVT to receive the reduced room rate.

Workshop 8:30 AM – 12:00 PMRapid Microbiological Testing: Calculating the Value,Choosing the Right Method, Validating, and CaseStudies Using an Automated Non-DestructiveEnumeration SystemGrace Thornhill, Ph.D.,Technical Director, P3 Scientific

Roger Deschenes, Director of Microbiology, AstraZeneca

Chris Paddison, Paddison Asssociates

David Jones, Ph.D., Director of Technical Services, GPS

Don Straus, VP Research, GPS

Andrew Sage, Principal Scientist, GPS

Roanna London, Senior Scientist, GPS

I. Choosing the Right Rapid Microbiology System• The spectrum of rapid micro systems that are available• Deciding which system is appropriate for your application• Regulatory Factors• Strategies for evaluating companies that sell rapid testing systems

II. Case Studies of Key Pharma Applications• Learning how the Growth Direct system works• Rapid testing data for key microbiology QC applications

• In process and product testing• Water and Environmental monitoring• Sterility testing

III. Validating Rapid Microbiology Systems • Successful validation strategies• Validating rapid methods in the U.S. and Europe• Streamlined strategy for validating rapid methods under USP

Chapter <16> for automated compendial tests• Rapid methods that have been recently validated

IV. Interactive Exercise: How to Justify Purchase of aRapid Micro System

Attendees will learn how to outline the components of a costjustification for purchase of Rapid Microbiological capital equip-ment. The final interactive session will demonstrate how to cal-culate the Return on Investment (ROI) of a rapid testing system.

Half-Day Workshop Validating Microbiological Test MethodsTony Cundell, Ph.D., Director, Pharmaceutical Sciences - Microbiology

Schering-Plough Research Institute (SPRI) Invited Speaker

(Session details unavailable for print. Check www.ivthome.com forupdates.)

12:00 PM – Luncheon

1:15 PMEnvironmental Monitoring a Risk IssueDiana Garcia-Flores, BS, Microbiologist Team Leader, Natural AlternativesInternational

This session will address critical issues to consider when designingan environmental program involving multiply products.The discus-sion will focus on potential contributors to environmental chal-lenges and how to prevent contamination of critical and non criticalareas by taking a risk management approach.

• Understanding your facility layout• Why proper training of personnel is critical• Equipment and other components• An overview of validation of aseptic process• Environmental monitoring- establishing a general written

program

2:00 PMManaging Investigations in Response to Alert/ActionLevels Excursions and Adverse Trends in anEnvironmental Monitoring ProgramFrancesco Boschi, QC Microbiology Manager, Monza Operations,Patheon Italia

This session will provide guidance and tools for the management ofalert and action levels, excursions, and adverse trends within viableEM Programs. Key issues such as unexpected data confirmation,investigations, corrective and preventive actions, and implementa-tion and follow-up, will be reviewed both from a regulatory andpractical point of view.

• Alert/action levels for viable EM monitoring• EU and U.S. regulatory requirements• Management of out-of-level (OOL) and adverse trends• Carrying out an effective investigation: development of a

check-list• Planning a feasible Corrective and Preventive Actions (CAPA)

plan


3:15 PMRecognition and Mitigation of Microbiological Risksin Aseptic ProcessingDr. Klaus Haberer, Managing Director, Compliance, Advice and Services inMicrobiology, Expert of the EP

Aseptic processes are among the most exacting procedures in phar-maceutical manufacturing. Media fill simulations are used to vali-date the aseptic procedures, and environmental monitoring isexpected to reveal abnormal situations where the validated condi-tions for successful manufacturing of sterile product are not met.This presentation will feature how to recognize and mitigate micro-biological risks in aseptic processing.

• The significance of monitoring results and positives in media fills

• Determining where and how samples should be taken to givethe most useful information on the process

• The significance of monitoring results • Evaluating excursions to best recognize risks to the process,

and how should such risks be mitigated?

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Thursday, June 22, 2006Half-Day Interactive Workshops

Thursday, June 22, 2006Main Conference General Sessions

4:00 PMEfficiency with Rapid Microbiological Methods: A Practical ApproachManish Gandhi, Lead Microbiologist, Leiner Health Products

This session will evaluate the competence of the conventionalmicrobiological methods. It will explore the need for a RapidMicrobiological Methods (RMM) in a production laboratory.Perform the cost vs. benefit analysis of the RMM.This session willpresent tips on measuring the efficiency with RMM, and will com-pare the efficiency of RMM with that of a conventional method.

• Evaluating the need for a RMM• Knowing the potentials of a RMM• Performing cost vs. benefit analysis for a RMM• A scientific approach in evaluating the efficiency

4:45 PMUpgrading Competency of Microbiologists in thePharmaceutical IndustrySumant Baukhandi, Ph.D., Director, Pharma Institute of GMPs, India

President – Regulatory Affairs & Quality Affairs, Orchid Chemicals &Pharmaceuticals Ltd., India

This session will address training needs and methodology to beemployed when training and upgrading microbiologists in thePharma industry.The need to know rationale and theory of differentmicrobiological aspects shall also be discussed. It shall also covertraining considerations for QC microbiology laboratory.

• Why should microbiologists be highly competent?• Training microbiologists to upgrade their competency• How microbiologists contribute to quality and sterility assurance• Identifying skills required for microbiologists

5:30 PM – Conclusion of Main Conference


Session 8:30 AM – 10:00 AMAn Overview of Methods for the Identification ofFilamentous FungiStacy O. Montgomery, Ph.D., Director, Global Marketing, Biolog Inc.

I. Basics of Fungal Classification and SystematicsII. Diversity of the Fungal World

• Beneficial processes of filamentous fungi:• Their production of novel bioactive metabolites• Their ability to cause serious disease

• The importance of identifying fungal contaminants:• An aging population and increase in the numbers of

immuno-compromised individuals• Organisms that were once considered harmless saprophytes

have now been shown as etiological agents of diseaseIII. Identification of Filamentous Fungi

• Classical macroscopic and microscopic morphology• Biolog Carbon Source Utilization• MicroSeq rRNA gene sequencing

IV. Advantages and Limitations of Each Method

Session 8:30 AM – 10:00 AMMicrobial Excursions and Investigations in WaterSystems – Essential, But Too Often Fruitless Teri C. (“T.C.”) Soli, Ph.D., Consultant, Soli Pharma Solutions, Inc.


I. What is a Microbial Deviation or Excursion?• The crucial roles of sampling and the test method• Learning how to and how not to establish action levels• Significance of action level and specification excursions

II. Investigating the Cause and Correcting MicrobialExcursions

• Most frequent non-water system causes of excursions• Outlet-specific excursions and system-wide excursions• Instituting corrective actions and assessing effectiveness

III. Investigating the Product and Process Impact ofMicrobial Excursions

• Scope of potential impact and the criticality of fast action• Identifying specific product and process sensitivities• Understanding the role of product testing and challenging

IV. Minimizing the Occurrence and Impact ofMicrobial Excursions

• Learning simple sampling improvements that avoid most ofthe non-verifiable excursions

• Learning how to minimize excursion impacts on product • Inappropriate alternatives for reducing excursions

V. Interactive Exercise: Attendee ProblemTroubleshooting

In every group of participants, at least one person will have somepast or present microbial excursion issue with their water systemback home that they are willing to share as a learning exercise inorder to get real answers and problem resolution options.


Attendees will receive a copy of the latest revision to <1231>from USP29 which addresses this subject and can be used as areference.

Session 8:30 AM – 10:00 AMMicrobial Limits Test-Harmonization Review andImpact of Changes Tony Cundell, Ph.D., Director, Pharmaceutical Sciences - Microbiology

Schering-Plough Research Institute (SPRI) Invited Speaker

(Session details unavailable for print. Check www.ivthome.com forupdates.)

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Thursday, June 22, 2006Main Conference General Sessions

Friday, June 23, 200690-Minute Interactive Sessions


Session 8:30 AM – 10:00 AM Microbiology Training ProgramsJackie Hewitt, Microbiology Manager, Luitpold Pharmaceuticals

I. Regulatory Requirements• Agency Expectations • What is required under GMPs and GLPs• Are there certification programs relevant to pharmaceutical

microbiology labs?II. Planning a Training Program

• Structuring your training program• Training for microbiology personnel• SOP training, proficiency training, and competency evaluations.

III. Proficiency Training• Understanding the stages of proficiency training• Working through training on typical microbiological tests

IV. Competency Evaluations • Requirements for frequency of evaluations• Structuring evaluations: individual tests or general competency• Gaining insight into performance of competencies

V. Interactive Exercise and Discussion Attendees will have the opportunity to plan a program and acompetency evaluation checklist while discussing the relativemerits of different approaches.

Session 8:30 AM – 10:00 AMGet Real-Time Results in Microbiology for AirMonitoring –Get Proactive!Pascal Yvon, C.E.O., AES – Chemunex, Inc., Pharm.D., M.B.A.

I. How Does ScanRDI® Work?• Automating microbial detection capability without the

requirement of cell growth• Capturing microbial cells through filtration and labeling directly• Detecting cells directly without further treatment• Cell enumeration• Learning why ScanRDI is unique

II. Implementation for Environmental Monitoring• Process-water monitoring• Cell culture process monitoring• Environmental monitoring• Learning how ScanRDI can support proactive actions to air-

borne contaminationIII. How to Implement It Now?

• Scan RDI is 21 CFR Part 11 compliant• Drug Master File registered• Validation package available• Learn how to take advantage of ScanRDI right now

IV. Polym’Air®• Inert and non-selective support enabling the collection of all

airborne microorganisms with an air sampler• Make real-time decisions• Manipulations will be performed during the interactive session

V. Conclusion• Real-time detection and enumeration of microorganisms

without the need for cell growth• Proactively respond to airborne contamination

10:00 AM – Refreshment Break

Session 10:30 AM – 12:00 PMThe Outsourcing of Microbial Identifications: What’sin a Name? Mike Edgington, M.Sc, CEO, Edgington Associates, BV Sassenheim theNetherlands

I. What is in a Name? • Why do we identify?• FDA and European requirements

II. Why Should I Outsource? • Exploring the reasons• Pros and cons

III. Outsourcing Identifications What QualityStandard?

• Determining when GMP applies• Deciding where GMP cannot be applied• Audits of the CRO sub-contractor

IV. Classification and Methodology• Phenotypic and Genotypic methods• Comparing apples with pears• 483 and Warning letters concerning ID’s

V. Interactive Exercise: Developing DocumentsAttendees will learn the values of phenotypic and genotypic ID methods.


A key point checklist to assist in decisions to do it yourself oroutsource.

Session 10:30 AM – 12:00 PMPlanning, Implementing, and Validation Isolators forSterility TestingJackie Hewitt, Microbiology Manager, Luitpold Pharmaceuticals

I. The Concept of Isolation Technology for SterilityTesting

• Isolation technology for sterility testing and its advantages• Implications of results obtained using isolators to product

release/ batch disposition• Regulatory responses to introduction of this technology

II. Planning Installation of Isolators for SterilityTesting

• Understanding space required and design of area for isolators• Determining the utility and support requirements

III. Implementation of the Isolator System• Lead-times, stages in manufacture of the system• Working with the manufacturer for smooth installation and IQ/OQ• Using manufacturer or consultant validation services

IV. Validation of an Isolator System for SterilityTesting

• Issues involved in performance qualification• How the microbiology lab is involved in the testing• Additional qualifications that add to flexibility in using the isolator

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V. Using an Isolator for Sterility Testing• Training and operating issues with sterility testing in isolators

Session 10:30 AM – 12:00 PMChallenges and Considerations when Implementingan Electronic Environmental Monitoring DataManagement SystemGeorge M. Levinson, President, Compliance Software Solutions Corp.

I. Automating an Environmental MonitoringProgram

• Key elements of a documented environmental control program• Industry trends, regulatory requirements, and current

compliance challenges• System requirements

II. Trending, Reporting and Analyzing the Data• Learning the benefits of trending data• Recognizing what the trends are telling you

III. Selecting the Right Environmental DataManagement System

• Selecting a suitable software program solution• Automation options• Creating vendor selection criteria and audit requirements• Defining training needs and resources

IV. Implementing and Validating of Your SolutionOption

• Licensing, maintenance, and support of your software• Configuring the software now and in the future• Knowing what is needed to perform the IQ, OQ, and PQ• Learning what to look for in security options

Session 10:30 AM – 12:00 PMWater System Validation: Who is it for and HowMuch is Enough?Teri C. (“T.C.”) Soli, Ph.D., Consultant, Soli Pharma Solutions, Inc.


I. Before You Begin Validating Your Water System • Understanding the impact of your starting water quality• How the purification process and microbial control flexibility

impact success• The microbial test method you plan to use• Your initial alert and action levels

II. Water System Validation Exercise Benefits• Water system builder, owner, and user benefits• Overall company benefits• Minimum regulatory expectations

III. Validation Road Maps – The Protocols• Learning how the beneficiaries and regulatory expectation

shape the “size” of the validation• How future water system problems may reflect superficial ini-

tial validation, poor change control, or a poor choice of ActionLevel criteria

• How future assurance is proportional to initial validation effort

IV. Interactive Exercise: Attendee ProblemTroubleshooting

In every group of participants, at least one person will have somepast or present microbial excursion issue with their water systemback home that they are willing to share as a learning exercise inorder to get real answers and problem resolution options.

V. Participants Will Take Home the Following Bonus Information

• A copy of the latest revision to <1231> from USP29 whichaddresses this subject and can be used as a reference.

Session 10:30 AM – 12:00 PMAchieving Microbiological Control in Clean RoomsSanjit Singh Lamba, Director-Pharmaceutical Manufacturing, RanbaxyLaboratories Limited, India

I. How to Achieve Contamination Control • Controlled environments• Sterilization• Cleaning and disinfection program• Aseptic gowning• Trained and qualified personnel

II. How to Achieve Controlled Environment• Construction of facility as per clean construction protocol• Validating clean rooms• Critical and controlled environment• Unidirectional air flows• Environment monitoring

III. Sterilization of Equipment and Container /Closures

• Learning about qualification approach • Controlling bacterial endotoxins

IV. Cleaning and Disinfection Program• Variables in disinfection process• Qualification of disinfectants

V. Aseptic Gowning• Selection of gowning• Gowning certification program• Microbiological assessment of gowning and gloves

VI. Trained and Qualified Personnel• Contamination control manual• Clean room behavior• Aseptic media fill

VII. Interactive ExerciseThe interactive session will include examples, observations and a case study of a facility about a new facility startup.Theprogram will also discuss operator interventions in the asepticprocess that can lead to contamination.


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Session 1:30 PM – 3:00 PMNon-Sterile Manufacturing Environment – Out ofSpecification (OOS) and Out of Trend (OOT) ResultsHandlingRanga Velagaleti, Ph.D., Senior Regulatory Specialist, BASF Corporation

I. Guidelines for OOS and OOT Investigations• Definitions of OOS and OOT Results• Global regulations governing specifications and OOS results• Compendial guidelines for OOS and OOT results• Case study examples of non-compliance of regulations gov-

erning established specifications• Reviewing FDA’s Out of Specification Guidance

II. Alert and Action Levels for DI Water• Water quality expectations for non-sterile pharmaceutical

manufacturing• How do the water system designs facilitate such quality pro-

duction of water? • Monitoring microbiological quality of water• Biofilms and their impact on microbial bioburden

III. Alert and Action Levels for Environment andEquipment

• Key factors to consider in a non-sterile pharmaceutical manu-facturing facility

• Microbiological sampling for equipment and environment• Techniques and methods available for microbial monitoring

of environment and equipment IV. Alert and Action Levels and Specifications for

Raw Materials and Finished Products• Current requirements for raw material and product testing • Raw material and product specifications• OOS and OOT Investigations• Product Recalls

V. Interactive ExerciseThe interactive session will include four problems for discus-sion and participants will discuss how these problems couldbe resolved.


• Microbiology Guidance from Industry and FDA

Session 1:30 PM – 3:00 PMBenefits of a Polyphasic Approach to MicrobialIdentificationGary Jackoway, Vice President, Research and Development, MIDI, Inc.

Gerard Osterhout, Research and Development Lab Manager, MIDI Inc.

I. Two Bacterial Identification Techniques: 16S DNAand FAME

• How identification by 16S sequencing works• Advantages and disadvantages of 16S sequencing• How identification by Fatty Acid Methyl Esters (FAME) works• Advantages and disadvantages of FAME

II. The Principle of Orthogonality• The theoretical basis of orthogonality and independence• Application to bacterial identification: phenotypic and geno-

typic identification• Bringing orthogonal techniques together

III. Interactive Exercises: A Sampling of PolyphasicResults

Participants will evaluate real-world examples, including:increasing confidence by confirmation using two techniques;disambiguation of indeterminate results from each technique;and resolving conflicting results from the techniques.

IV. Continuing Work: Where do we go From Here• Polyphasic metrics• Application of domain-specific knowledge• Poly means more than two!


• Examples of real-world samples• Approaches to future work• Identification systems as tools for the microbiologist

Session 1:30 PM – 3:00 PMQuality Agreements with Microbiology ContractorsMike Edgington, M.Sc, CEO, Edgington Associates BV Sassenheim, theNetherlands

I. FDA and International Requirements • FDA and European requirements• The role of ISO• Learning the difference between the requirements

II. Good Laboratory Practice Requirements (GLP):• Role of management• Role of the study director• Role of principle investigator (scientist)• Role of quality assurance

III. When do I Need GMP and Why is it Called GCLP?• Release tests• The CRO as part of your establishment or manufacturing

license• Audits of the CRO sub-contractor vs. regulator

IV. What Should be Specified in the Contract?• Documentation• Change controls• OOS investigations• Defined authorization and role of authorized persons

V. Interactive Exercise: Developing Documents• Attendees will draw up an agreement for sterility testing.

IV. Participants Will Take Home the Following Bonus Information

• A key point checklist to review the quality agreements

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Session 1:30 PM – 3:00 PMSelection of Microbiological Methods for PurifiedWater Analysis Rick Jakober, Vice President Laboratory Services, Perritt Laboratories,Inc.

I. Microbiological Regulations for PharmaceuticalWater

• USP and EP – current requirements • Guidance documents and sources • Regulatory expectations

II. Microbiological Qualification of a Water System • What are we monitoring for? • Selection of media • Membrane filtration vs. pour plate • Volume, incubation time and temperature

III. Microbiological Monitoring • Initial monitoring (OQ) • Routine monitoring (PQ and beyond) • Microbial identification • Setting microbial specifications

IV. Interactive Exercise Participants will discuss selected microbial monitoring regi-mens and analyze optimal microbial recovery strategies.

Session 1:30 PM – 3:00 PMTaking a Look at Environmental Program for Non-Aseptic ManufacturingDiana Garcia Flores, BS, Microbiologist Team Leader, Natural AlternativesInternational

I. What Type of Product is Being Manufactured• Identifying regulations required• What safety and health issue should be considered

II. Issues to Consider When Designing anEnvironmental Monitoring Program

• Why facility layout is vital to your environment program• Identifying who is qualified to execute the EM program• HVAC system, pressure, temperature and humidity• Why routine testing is crucial• The importance of having SOPs in place.

III. Interactive ExerciseAttendees will be asked to help design a general written program of a non sterile manufacturing environment.


Session 3:30 PM – 5:00 PMRegulatory, Technical and Logistics Aspects ofMicrobial Bioburden MonitoringRanga Velagaleti, Ph.D., Senior Regulatory Specialist, BASF Corporation

I. Global Regulations; Compendial, and FDAGuidelines for Microbiology of Non-SterilePharmaceutical Manufacturing

• U.S. and International GMP Microbiology regulations of a non-sterile pharmaceutical manufacturing environment

• Gaining an understanding of available PharmacopoeialGuidances in U.S., Europe and Japan

• Reviewing available guidance related to regulatory inspectionsII. Microbiology of Water Used for Non-Sterile

Pharmaceutical Manufacturing• Recent changes to USP General Chapter <1231> Water

for Pharmaceutical Use and impacts on non-sterile pharmaceutical manufacturing

• Biofilms and their impact on microbial bioburden in water systemsIII. Microbiological Monitoring in Non-Sterile

Manufacturing• Microbiological sampling for equipment and environment –

sampling during manufacture or sampling after wet cleaning? • Microbial monitoring of environment and equipment in a

non-sterile manufacturing facility.IV. Microbiology of Pharmaceutical Raw Materials

and Finished Products• Current requirements for raw material and product testing

based on regulatory and compendial expectations• Manufacturing process flow – containment• Methods and procedures used for testing and their validation • Product recalls and specification release

V. Interactive ExerciseParticipants will be presented with four problems to resolve

Session 3:30 PM – 5:00 PMCurrent Trends in Aseptic Process Simulations: RiskAnalysis Approach for Failure Investigations Dona Reber, Director of Microbiology, Global Quality Operations, Wyeth,Collegeville, PA

Mary Griffin, Associate Director, Microbial Science & Technology, WyethBiotech, Andover, MA

I. Overview of Aseptic Process Simulations (APS)• Understanding purpose of media fills• Routine and non-routine interventions• Identify personnel• Review media and incubation conditions

• Growth promotion• Integral and non-integral containers• Animal vs. vegetable based media for APS

II. Investigation Guidance• Discussing the relationship of the type of organism and poten-

tial root cause • Understanding the impact of failed units• Genotypic methods for microbial strain relatedness

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III. Corrective Actions• Reviewing potential changes in equipment, process design,

and environmental improvements• Reviewing personnel training records, practices, and trends

IV. Determine Product ImpactV. Requalification

VI. Interactive Session: Case StudiesUsing FMEA (Failure Mode and Effect Analysis) as a tool, attendeeswill review investigations for failed aseptic process simulationsand determine risk levels and the potential cause and effect.

VII. Participants Will Take Home the Following Bonus Information

• Example of FMEA tool for template

Session 3:30 PM – 5:00 PMMicrobiological Method Development for Non-SterilePharmaceuticals Rick Jakober, Laboratory Manager, Perritt Laboratories, Inc.

I. Compendial Requirements for ValidatingMicrobiological Methods for Non-SterilePharmaceuticals

• EP, JP, USP requirements for validating microbiological methods for new compounds

• Setting specifications for new materials and products• Regulatory expectations for new method development

II. Preservative Systems for Pharmaceutical Products• Preservative systems for non-sterile pharmaceutical products • Neutralization steps for chemically preserved samples • Strategies for neutralization of preservative systems

III. Method Development for Microbial Content Testsand Presence of Objectionable Organisms

• Techniques for validating microbial plate counts • Validating enrichment tests for objectionable organisms • Case studies of unusual plate count and enrichment procedures

IV. Method Development for AntimicrobialEffectiveness Testing (AET)

• Review AET test categories• Preservative neutralization strategies for AET testing

V. Interactive Exercise: Neutralization Strategies In this exercise, participants will be given a variety of scenarioswith different types of neutralization strategies for validationsof plate counts, and enrichments for microbial content tests,enrichment tests for objectionable organisms, and preservativechallenge tests. Participants will perform calculations and deter-mine the optimal methodology for each type of product.

Session 3:30 PM – 5:00 PMBiological Indicators: Their Use and AbuseMike Edgington, M.Sc, CEO, Edgington Associates, BV Sassenheim, theNetherlands

I. FDA and International Requirements • Pharmacopoeia Requirements for BI’s• USP, Ph.Eur, ISO• Learning about the difference between the requirements

II. BI’s for Different Applications• Steam, radiation, dry heat, vapor phase hydrogen peroxide • Learning to choose the right model• Setting up and using a virtual private network (VPN)

III. Considering the Factors That Effect BI D-valueand Performance

• Media, humidity, type of carrier• Deciding between open or enclosed systems• Control of BI’s quality• Incoming QC testing parameters• The supplier audit

IV. Interactive Exercise: Developing DocumentsUsing a case study of BI failure investigations, attendees willdevelop an understanding of dealing with the unexpected andwill learn what inspectors want to see.


• A key point check list to audit a BI supplier

Session 3:30 PM – 5:00 PMEvaluating Microbial Identification Methods forPharmaceutical Manufacturing – A PracticalApproach Stacy O. Montgomery, Ph.D., Director, Global Marketing, Biolog Inc.

I. Commercially Available Identification Systems • Phenotypic Systems:• Genotypic Systems:

II. Determine the Most Appropriate ID System forYour Laboratory and Level of Throughput

• Accuracy • Automation• Reproducibility • Time to Result• Cost of Platform • Ease of Use• Cost per Sample • Ease of Interpretation

III. Microbial Identification Databases • “Why and how” to grow your own

IV. Recent FDA Aseptic Processing Guidance• What impact it may have on your choice of identificationmethods

V. Species Level Identification vs. Strain LevelCharacterization.

VI. Determining When Strain Characterization isNecessary

• Discussing the current available methods

THANK YOUIVT would like to extend our sincerest gratitude to Dr.TonyCundell and Dr.T.C. Soli for assisting with technical advice; andto Dr. Jeanne Moldenhauer for support with coordinating theSterilization Applications Session.

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Microbiology Event of the YearJune 20-23, 2006 • Washington, DC • Hamilton Crowne Plaza


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TUESDAY, JUNE 20, 2006

7:30 AM Registration andBreakfast

Half-Day InteractiveWorkshops A, B, C, D, E

8:30 AM Course Begins

10:00 AM – 10:30 AMRefreshment Break

12:00 PM – 1:30 PM Luncheon

WORKSHOP A (Ganatra)

Validation of Rapid MicrobiologicalMethods

WORKSHOP B (Jiang)

Real-Time Optical Sensors forMicrobial and EnvironmentalMonitoring

WORKSHOP C (Fontana)

Water Activity for ReducedMicrobial Testing Using USPMethod <1112>

WORKSHOP D (Dolan/O’Hare/Vincent)

Strategies for Establishing aCompliant EnvironmentalMonitoring Program

WORKSHOP E (Waddington)

Identification and Characterizationof Microorganisms UsingMolecular Methods


Main Conference GeneralSessions

1:00 PM (Tirumalai/Haberer/Sasaki)USP, EP, JP Current Activities

2:15 PM (Soli)Late Breaking Developments fromthe USP Pharmaceutical WaterExpert Committee


3:15 PM (Sasaki) Compendial Requirements for theDetection of MycoplasmaContamination from Cell Cultures

4:00 PM (Baukhandi)Bacterial Endotoxins and theirInactivation

4:45 PM (Moldenhauer)Getting a Rapid Sterility TestApproved - Case Studies

6:00 PM –7:00 PM Networking Cocktail Reception Sponsored by

WEDNESDAY, JUNE 21, 2006

7:30 AM Breakfast

8:15 AM Sterilization Applications Begins


12:30 PM Sterilization ApplicationsConcludes

2:00 PMGroup Excursion –Smithsonian NationalMuseum of Natural History

6:30 PM Cocktail Reception

7:30 PM Awards Dinner, and Keynote Speaker

9:00 PM Conclusion

THURSDAY, JUNE 22, 2006

Half-Day InteractiveWorkshops: F, G, H, I, J

7:30 AM Breakfast

8:30 AM Course Begins


WORKSHOP F (Soli)

Validating Microbial EnumerationMethods for Water

WORKSHOP G (Vincent/Boschi)

Preparing for an Audit of the QC Laboratory

WORKSHOP H (Clontz)

Microbiological Control inManufacturing

WORKSHOP I (Thornhill et al.)

Rapid Microbiological Testing:Automated Non-DestructiveEnumeration System

WORKSHOP J (Cundell)

Validating Microbiological Test Methods


Main Conference GeneralSessions

1:15 PM (Garcia-Flores)Environmental Monitoring a Risk Issue

2:00 PM (Boschi)Managing Investigations in an EM Program


3:15 PM (Haberer)Recognition and Mitigation ofMicrobiological Risks in AsepticProcessing

4:00 PM (Gandhi)Rapid Microbiological Methods:A Practical Approach

4:45 PM (Baukhandi)Upgrading Competency ofMicrobiologists in thePharmaceutical Industry

5:30 PM Conclusion of Main Conference

FRIDAY, JUNE 23, 2006


90-Minute Post-ConferenceInteractive Sessions 1-5 8:30 AM – 10:00 AM

SESSION 1 (Montgomery)

Methods for the Identification ofFilamentous Fungi

SESSION 2 (Soli)

Microbial Excursions andInvestigations in Water Systems

SESSION 3 (Cundell)

Microbial Limits Test-Harmonization Review and Impact of Changes

SESSION 4 (Hewitt)

Microbiology Training Programs

SESSION 5 (Yvon)

Real-Time Results in Microbiologyfor Air Monitoring

10:00 AM – Refreshment Break

90-Minute Post-ConferenceInteractive Sessions 6–1010:30 AM – 12:00 PM

SESSION 6 (Edgington)

Outsourcing of MicrobialIdentifications

SESSION 7 (Hewitt)

Planning, Implementing andValidating Isolators for SterilityTesting

SESSION 8 (Levinson)

Electronic EnvironmentalMonitoring Data Systems

SESSION 9 (Soli)

Water System Validation

SESSION 10 (Lamba)

Microbiological Control in Clean Rooms


90-Minute Post-ConferenceInteractive Sessions 11–151:30 PM – 3:00 PM

SESSION 11 (Velagaleti)

OOS and OOT Results Handling

SESSION 12 (Jackoway/Osterhout)

Polyphasic Approach to MicrobialIdentification


Quality Agreements withMicrobiology Contractors

SESSION 14 (Jakober)

Selection of MicrobiologicalMethods for Purified WaterAnalysis

SESSION 15 (Garcia-Flores)

Environmental MonitoringProgram for Non-AsepticManufacturing


90-Minute Post-ConferenceInteractive Sessions 16–203:30 PM – 5:00 PM

SESSION 16 (Velagaleti)

Regulatory,Technical, and LogisticsAspects of Microbial BioburdenMonitoring

SESSION 17 (Reber/Griffin)

Risk Analysis Approach for FailureInvestigations

SESSION 18 (Jakober)

Microbiological MethodDevelopment for Non-SterilePharmaceuticals


Biological Indicators:Their Use andAbuse

SESSION 20 (Montgomery)

Evaluating Microbial IdentificationMethods

■■ The Ultimate Passport $2695 USDAttend the entire event at this best value price.The Passport Includes:• One Half-Day Interactive Workshop and

Main Conference General Sessions on Tuesday• Sterilization Applications Session, Group Tour and

Awards Dinner on Wednesday• One Half-Day Interactive Workshop and Main Conference

General Sessions on Thursday• Four Interactive Sessions on Friday • Networking Cocktail Reception • Conference Workbook with All Available Presentations

Passport registrants must check the boxes of the workshopsand sessions that they wish to attend!

Method of Payment: Please note that payment is required in advance of the conference. Pleasemake checks (in U.S. funds drawn on a U.S. bank) payable to IVT/Advanstar Communications.Confirmation of your registration will be sent. Full payment must accompany registration form.Registrations received without payment will not be processed.Cancellations/Substitutions: Your registration form may be transferred to a member of your organi-zation at any time. Requests for cancellations (by mail or fax) must be received by June 6, 2006 in orderto receive credit for attending another IVT event. Please be aware that cancellations will not be accept-ed after that date. All cancellations are subject to a $325.00 processing fee. IVT reserves the right tocancel an event. IVT is not responsible for any airfare, hotel, or other costs incurred by registrants.Speakers subject to change without notice.

COST TOTALS: MICROBIOLOGY EVENT OF THE YEAR

Tuesday, June 20, 2006Pre-Conference Workshops A – E $795 USD $ _____________

Tuesday – Thursday, June 20-22, 2006Main Conference, Sterilization Application Session& Inclusive Interactive Workshops $1995 USD $ _____________

Friday, June 23, 2006Post-Conference 90-Minute Interactive Sessions

Sessions 1 – 5 $395 USD $ _____________

Sessions 6 – 10 $395 USD $ _____________

Sessions 11 – 15 $395 USD $ _____________

Sessions 16 – 20 $395 USD $ _____________

ORThe Ultimate Passport $2695 USD $ _____________

SUB TOTAL $ _____________

TOTAL Enclosed $ _____________

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Federal Tax ID # 592757389


8:30 AM – 12:00 PM .......................................................... $795 USDA ■■ B ■■ C ■■ D ■■ E ■■ (Choose one)

■■ Tuesday - Thursday, June 20-22, 2006MAIN CONFERENCE: General Sessions,Sterilization Applications and Inclusive Interactive Workshops: .........................$1995 USD

Tuesday General Sessions1:00 PM – 5:30 PM

Wednesday Sterilization Applications,Group Excursion and Awards Dinner

■■ 2:00 PM Group Excursion ■■ 7:30 PM Awards Dinner(You must check the boxes to attend the events)

Thursday Half-Day Interactive Workshops8:30 AM – 12:00 PM

F ■■ G ■■ H ■■ I ■■ J ■■ (Choose one)

Thursday General Sessions1:15 PM – 5:30 PM

Friday, June 23, 2006Post-Conference 90-Minute Interactive Sessions

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3:30 PM – 5:00 PM...............................................................$395 USD16 ■■ 17 ■■ 18 ■■ 19 ■■ 20 ■■ (Choose one)

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Complete this registration form, include payment in U.S. funds, and send to:Advanstar/Institute of Validation Technology • PO Box 6004, Duluth, MN 55806-6004888.524.9922 (U.S. only) or 218.723.9130 (U.S. or international) • Fax: 218.723.9308 • E-mail: [email protected] • www.ivthome.com

MICROBIOLOGY EVENT OF THE YEAR • June 20-23, 2006 • Hamilton Crowne Plaza • Washington, DCFor hotel information see page 6.

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www.ivthome.com/nominate • All nominations must be submitted by JUNE 10, 2006

If you think one of your colleagues is an emerging leader, accomplished in pharmaceutical quality, and shows great promise,please visit web site www.ivthome.com/nominate for more detail and to submit your nomination now! Or perhaps you should be considered? Submit your own nomination! This award program was created to recognize and honor industry’smost talented microbiology professionals. As recipient of this honor, the Microbiologist of the Year will receive:

Submit your nomination for IVT’s MICROBIOLOGIST OF THE YEAR.

IVT is currently accepting nominations for this year’s MICROBIOLOGIST OF THE YEAR 2006!

Candidates can be self-nominated or peer-nominated.

IVT will select a qualified board to determine IVT’s MICROBIOLOGIST OF THE YEAR 2006.Nominees will be judged in one or more areas including:

• Microbiological advances • Achievements in microbiology

• Dedication to industry • Industry contribution

• IVT’s Microbiologist of the Year 2006 Award • The opportunity to be the honored guest of the 2006 dinner and award ceremony• Complimentary registration to IVT’s Microbiology of the Year Event in 2007• A feature article and biography in Pharmaceutical Technology published by Advanstar Communications, Inc.• A special announcement in IVT’s brochure and program guide on the MICROBIOLOGY EVENT OF THE YEAR 2007• A free one-year subscription to IVT’s Journal of Validation Technology or Journal of GXP Compliance

Congratulations to Dr. Tony Cundell

MICROBIOLOGIST OF THE YEAR 2005!