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ConferenceOctober 15-16 October 15-16

Exhibition October 17-18

Course

Register bySeptember 17

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Connecting People, Science and Regulation SM

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Connecting People, Science and Regulation ®

Program Planning Committee

John Shabushnig, PhD Pfizer Inc

Committee Co-chair

Markus Lankers, PhD Rap.ID GmbH

Committee Co-chair

Christina BogyoPDA

Roy CherrisBridge Associates International

Robert Dana

PDA

Julius Knapp

Research & Development Associates, Inc.

Wanda Neal-Ballard

PDA

Message froM the PrograM Co-Chairs

Dear Colleagues:

We are pleased to offer an exciting program once again at the 2007 PDA Visual Inspection Forum, October 15-16, in Bethesda, Maryland. We have assembled a comprehensive program designed to help both those new to the field as well as the experienced practitioner.

Attendees will learn about current regulatory and compendial expectations for inspection from invited FDA and United States Pharmacopoeia speakers. The program also includes an overview of new inspection technologies and techniques.

Highlights of this year’s PDA Visual Inspection Forum include:•Packagingmaterialssession–NewtothePDAVisualInspectionForum!•UpdatesonPDA Technical Report No. 43 – Glass Defects•Casestudiesofimplementinginspectionsystemsandprograms•Roundtablediscussionwithconferencespeakers•Morethan12hoursofnetworkingtime,includinganetworkingreceptionatthenewPDATrainingandResearchInstitute(TRI)facilityanddinnerreceptionatPositanoItalianRestaurant

•Exhibitorsofinspection-relatedservicesonhandtodisplaycurrentcommercially available technology

Immediatelyfollowingtheforum,PDATrainingandResearchInstitutewilloffera two-day, hands-on training course in Visual Inspection, at the conference site. Coursespaceislimitedto20students,soweencourageyoutoenrollearly.More information on this course can be found on page 8.

We invite you to participate in the forum and attend the training course to learn from industry representatives as well as share your ideas and challenges with colleagues. We all benefit when we share our combined experiences and knowledge in inspection science, technology and regulation.

We look forward to seeing you this fall.

BestRegards,

Who Should attend

Pharmaceutical/Biopharmaceutical Manufacturers

EngineeringManufacturing

Packaging Process Development

Quality Technical Services

Validation

Pharmaceutical/Biopharmaceutical Developers

ClinicalSuppliesParenteral Development

Process Development

Inspection Equipment SuppliersApplications Development

Machine Design Sales

John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer Inc

2007 PDA Visual Inspection Forum Program Planning Committee Co-chairs

Markus Lankers, PhD, Managing Director, Rap.ID GmbH

Connecting People, Science and Regulation SMConnecting People, Science and Regulation SM

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3:00 p.m. – 7:00 p.m. Registration Open

5:00 p.m. – 7:00 p.m. PDA TRI Networking ReceptionPDA Training and Research InstituteBethesdaTowers,Suite1504350EastWestHighwayBethesda, Maryland

For conference attendees and exhibitors only

agenda

Sunday, October 14, 2007

Monday, October 15, 2007

7:30 a.m. – 8:30 a.m. Continental Breakfast

7:30 a.m. – 4:30 p.m. Registration Open

8:30 a.m. – 8:45 a.m.Welcome and Opening Remarks John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer IncMarkus Lankers, PhD, Managing Director, Rap.ID GmbH2007PDAVisualInspectionForumProgramPlanningCommitteeCo-chairs

8:45 a.m. – 10:30 a.m. Plenary Session 1: Industry Practices and Regulatory Expectations

Moderator: Robert Dana, VicePresident,QualityandRegulatoryAffairs, PDA

This session will offer attendees the opportunity to learn about regulatory aspects of visual inspection. FDA, US Pharmacopeia representatives and industry experts will provide an overview regarding today’s industrial and regulatory practices.

8:45 a.m. – 9:15 a.m.FDA Perspective on Visual InspectionCarole Jones,ConsumerSafetyOfficer,DMPQ/CDER, FDA

9:15 a.m. – 9:45 a.m.USP Parenteral Products/Industrial Expert Committee Update D. Scott Aldrich, PhD, President, Scientific Affairs, Ultramikro, LLC

9:45 a.m. – 10:15 a.m.Risk-based Classification of Visual Defects for Injectable ProductsJohn Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer Inc

10:15 a.m. – 10:30 a.m.Q & A

10:30 a.m. – 11:00 a.m.Refreshment Break and Poster Presentations in Exhibit Area

10:30 a.m. – 3:00 p.m.Exhibit Area Open

11:00 a.m. – 12:00 p.m.Plenary Session 2: Techniques and Technology (Part 1)

Moderator: Roy Cherris, Managing Partner, Bridge Associates International

Visual inspection performance is a function of consistency in visual inspection technique and practices. This session will review visual inspection variables and look at a standardized approach to utilize a specialized inspection station with particle imaging/sizing capabilities.

11:00 a.m. – 11:30 a.m.Accurate NIST Traceable Dimensions of Visible Particle Contamination Data in Sealed Containers of Injectable Products: An Essential Validation and Product Acceptance Tool Julius Knapp, Principal, Research & Development Associates, Inc.

11:30 a.m. – 12:00 p.m.An Improved Analytical Technique for the Accurate Sizing of Contaminating Particles in Clear Pharmaceutical Solutions Filled in Tubing Vials Gerald Budd, President, Phoenix Imaging

12:00 p.m. – 1:00 p.m. Exhibitor Roundtable Luncheon

1:00 p.m. – 2:30 p.m.Plenary Session 3: Techniques and Technology (Part 2)

Moderator: Markus Lankers, PhD, Managing Director, Rap.ID GmbH

To understand and characterize inspection performance, reliable standards and knowledge of appropriate statistical tools are required. This session will examine the statistical implications of sampling plans and the preparation and use of standards in the characterization of visual inspection operations.


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1:00 p.m. – 1:30 p.m.Defects, Acceptable Quality Level and Quality: What is the Risk? Rebecca Elliott, ResearchScientist,MS&TStatistics,Eli Lilly and Company

1:30 p.m. – 2:00 p.m.A Risk-based Approach for the Inspection of Lyophilized Products Karen Bossert, PhD, Vice President, Scientific Affairs, Lyophilization Technology, Inc.

2:00 p.m. – 2:30 p.m.Enumeration and Characterization of Visible Particles Using Flow MicroscopyDeepak Sharma, PhD, SeniorResearchScientist,Brightwell Technologies, Inc.

2:30 p.m. – 3:00 p.m. Refreshment Break and Poster Presentations in Exhibit Area

3:00 p.m. – 4:30 p.m.Plenary Session 4: Particulate and Foreign Material Identification

Moderator: Julius Knapp, Principal, Research & Development Associates, Inc.

The identification of particulate and foreign material is a critical step in process control. This session will include discussions on both instrumental and microscopic methods.

3:00 p.m. – 3:30 p.m.Understanding Particulate Matter in Biopharmaceutical ProductsMarkus Lankers, PhD, Managing Director, Rap.ID GmbH

3:30 p.m. – 4:00 p.m. Characterization and Control of Particulate Matter in Lyophilized or Powder-filled ProductsRoy Cherris, Managing Partner, Bridge Associates International

4:00 p.m. – 4:30 p.m.Particle Identification Facilitated by Visual Inspection D. Scott Aldrich, PhD, President, Scientific Affairs, Ultramikro, LLC

5:30 p.m.Depart from hotel

6:00 p.m. – 8:00 p.m. Reception and Dinner at Positano Italian Restaurant (Plaza Room)Forattendeesandexhibitorsofthe2007PDAVisualInspectionForum(hotbuffetandopenbar)

Positano Italian Restaurant4940-4948FairmontAvenueBethesda, MarylandTel:+1(301)654-1717Website: www.epositano.com


7:30 a.m. – 8:30 a.m. Continental Breakfast

7:30 a.m. – 10:00 a.m. Registration Open

10:00 a.m. – 3:00 p.m.Exhibit Area Open

8:30 a.m. – 10:00 a.m.Plenary Session 5: Packaging Materials

Moderator: John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer Inc

Packaging materials, such as glass vials and rubber stoppers, must be inspected along with the products they contain. During this session, speakers will discuss defects in packaging materials and strategies employed to detect and control them.

8:30 a.m. – 9:00 a.m.PDA Technical Report No. 43, Glass DefectsMichael Eakins, PhD,PrincipalConsultant,Eakins & Associates

9:00 a.m. – 9:30 a.m.High-speed Integrity Testing and Headspace Analysis for Pre-filled Syringes Gerhard Schramm, Sales Director, Wilco AG

9:30 a.m. – 10:00 a.m.Stopper QualityIndustry speaker invited

10:00 a.m. – 10:30 a.m. Refreshment Break and Poster Presentations in Exhibit Area

10:30 a.m. – 12:00 p.m.Plenary Session 6: Case Studies (Part 1)

Moderator: Markus Lankers, PhD, Managing Director, Rap.ID GmbH

Visual inspection standards are useful for inspector training, automated and semi-automated system qualification and method development. Furthermore, they can be used to connect the probability of detection of a particle and particle size. This session will focus on production and application of visual inspection standards.

10:30 a.m. – 11:00 a.m.Preparation and Use of Particle StandardsDan Berdovich, President, Micro Measurement Laboratories, Inc.

11:00 a.m. – 11:30 a.m. Formulation Design of Particle Standard Sets for the Characterization of Syringe Automated Inspection of Biologic Products Aarti Gidh, Scientist, Amgen

Monday, October 15, 2007 (continued) Tuesday, October 16, 2007


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Continuing eduCation Credit

PDAisapprovedbytheAccreditationCouncilforPharmacyEducation(ACPE)asaproviderofcontinuingpharmaceutical education. Following full attendance, completion and submission of the appropriate evaluation form(s),certificateswillbemailedwithinfourtosixweeksoftheevent.ContinuingEducationUnits(CEUs)will be awarded as follows:

2007 PDA Visual Inspection Forum1.150CEUsfor2.0days/FullConferenceACPE#116-000-07-087-L04

Learning ObjectivesAt the completion of this program, participants will be able to:• Identify particulate inspection methods and equipment• Identify critical parameters that affect the inspection process• Describe methodologies which reflect current industry

knowledge• Describe compendial requirements and regulatory trends to

insure their companies are meeting current and anticipated regulatory expectations

• Implement an effective and economical visual inspection process

11:30 a.m. – 12:00 p.m.Manual Inspection of Seeded Syringe Defects Compared to Automated Inspection for Automated Inspection of Biologic Products Deborah Shnek, Principal Scientist, Amgen

12:00 p.m. – 1:00 p.m.Speaker Roundtable Luncheon

1:00 p.m. – 2:30 p.m.Plenary Session 7: Case Studies (Part 2)

Moderator: Roy Cherris, Managing Partner, Bridge Associates International

This session will focus on practical experiences obtained in evaluating, implementing and validating visual inspection methods.

1:00 p.m. – 1:30 p.m.Training and Performance Monitoring of the Injectable InspectorMark Palkowski,SeniorManager/TL,InjectableManufacturing,Pfizer Inc

1:30 p.m. – 2:00 p.m.How to Buy an Automated Inspection Machine (User’s Point of View) Patrick Hanley, Senior Manager, Packaging Production, Genentech

2:00 p.m. – 2:30 p.m.Joint Quality and Cost Improvement by Selection of Sequential Inspection StrategiesJean Pierre Cesari, ComplianceDirector,GlobalQuality,Sanofi Pasteur

2:30 p.m. – 3:00 p.m. Refreshment Break and Poster Presentations in Exhibit Area

3:00 p.m. – 3:50 p.m.Plenary Session 8 – Panel Discussion

Moderator: John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer Inc

This session will foster open discussion on the subject of visualinspection, enabling attendees to learn from the experience of others. This is an opportunity to ask questions specific to your operation and to share some of your recent experiences. The panel is comprised of regulatory and compendial authorities, as well as knowledgeable scientists and users of inspection technology.

Panelists:D. Scott Aldrich, President, Scientific Affairs, Ultramikro, LLCPatrick Hanley, Senior Manager, Packaging Production, GenentechCarole Jones,ConsumerSafetyOfficer,DMPQ/CDER, FDA (invited)Julius Knapp, Principal, Research & Development Associates, Inc.

3:50 p.m. – 4:00 p.m. Closing Remarks and Meeting Summary John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer IncMarkus Lankers, PhD, Managing Director, Rap.ID GmbH 2007PDAVisualInspectionForumProgramPlanningCommitteeCo-chairs

2007 PDA Visual Inspection Training CourseInconjunctionwiththe2007PDAVisualInspectionForum,thePDATrainingandResearchInstitute(PDATRI)isofferinga course related to the latest technologies, newly-enacted regulations and updated processes in the pharmaceutical and biopharmaceutical industries.

Visual InspectionOctober17-18,2007|8:30a.m.–4:00p.m.PDA#417|ACPE#116-000-07-417-L04|1.2CEUsLocation: Hyatt Regency BethesdaInstructor: John Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer Inc

Who Should AttendThis course is designed for Engineers aswell asQualityManagersandSupervisors.Those inManufacturing,Researchand Development, and Validation departments would also benefit greatly.

Learning ObjectivesUpon completion of this training course, attendees will be able to:• Identify applicable international regulatory and compendial

requirements for visual inspection • Apply the critical parameters which must be controlled for

reproducible inspection results • Use appropriate statistical tools to assess and compare

inspection methods • Develop consistent validation strategies for visual inspection

processes and equipment


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Registration Fees (US$)

*Registrationfeeincludesaone-yearPDAmembership.** Must be a PDA member to receive this rate.

Please note: In order to receive the discounted registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Three Ways to Register1. CliCk www.pda.org/visinspect 2. fax +1(301)986-10933. Mail PDAGlobalHeadquarters Bethesda Towers 4350EastWestHighway Suite200 Bethesda,MD20814USA

Registration Hours(Badgepick-upandon-siteregistration)

Sunday,October14:3:00p.m.–7:00p.m.Monday,October15:7:30a.m.–4:30p.m. Tuesday,October16:7:30a.m.–10:00a.m.

Dress/AttireBusiness casual attire is recommended for 2007 PDA Visual Inspection Forum. Since the temperature in meeting rooms tends tobecool,pleasebringajacketorsweaterforyourcomfort.

Special RequirementsIf you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to [email protected].

general inforMation

Venuehyatt regenCy Bethesda

OneBethesdaMetroCenter(7400WisconsinAvenue)Bethesda,MD20814Tel: +1(301)657-1234Fax:+1(301)657-6453Website: www.bethesda.hyatt.com

Thegrouprateis$225singleand$250doubleoccupancy,plus12%stateandlocaltaxes.BookyourreservationbySeptember 23, 2007 to receive the PDA rate. Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early. Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant.

For conference information, contact:Christina BogyoSenior Manager, Programs and MeetingsTel:+1(301)656-5900ext.152Fax:+1(301)986-0296Email:[email protected]

For more information about obtaining a US visa, visit http://www.unitedstatesvisas.gov.


Exhibit and sponsorship opportunities available!The 2007 PDA Visual Inspection Forum is a great opportunity for your company to gain on-site exposure in front of highly qualified professionals in the pharmaceutical and biopharmaceutical industries. Manufacturers, Developers andInspectionEquipmentSupplierswillattendthiseventto stay abreast of new regulations and the science and technology to comply.

Exhibitatthe2007 PDA Visual Inspection Forum and let your company’s products or services become a valuable tool or resource for our attendees.

For more information, contact [email protected] or+1(301)656-5900ext.222.

Registration Fees (US$) Through September 17 After September 17

PDA Member $1,250 $1,450

Nonmember* $1,650 $1,850

Government $515 $595

Health Authority $515 $595

Academic** $515 $595

Student** $190 $225


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RegistrationForm

Contact Information

Mr. Ms. Dr.Name (first, middle initial, last)

Membership Number (for PDA members only) Job Title

Department Company

Mailing Address

City edoC latsoP/4+PIZecnivorP/etatS

Country E-mail

Business Phone Fax

Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for a member must pay the additional fee.)

:tnuoccA:tnuomA:kcehC:etaDYLNO ESU ADP

Registration is simple and fast...CLICK, FAX OR MAIL:

CLICK: www.pda.org/visinspect | FAX: +1 (301) 986-1093 (USA) | MAIL: PDA Global Headquarters, Bethesda Towers, Suite 200, 4350 East West Highway, Bethesda, MD 20814 USA

Connecting People,Science and RegulationSM

2007 PDA Visual Inspection Forum and CourseBethesda, Maryland • October 15 - 18, 2007

Conference Registration Please check appropriate fee (US$).

Through September 17 After September 17

Member $ 1,250 $ 1,450

Nonmember* $ 1,650 $ 1,850

Government/Health Authority $ 515 $ 595

Academic** $ 515 $ 595

Student** $ 190 $ 225

Wire Transfer Payments:If you require a wire transfer, please contact Patresa Day at [email protected].

By Bankers’ Draft Check forwarded togetherwith the registration form payable to:PDAP.O. Box 79465Baltimore, MD 21279-0465 USA

Overnight Deliveries:PDA c/o Suntrust BankLockbox 79465, 1000 Stewart AvenueGlen Burnie, MD 21061 USA

Invoice. Please mark here to request an invoicefrom PDA. You are not considered registered fora PDA course until payment is received and aconfirmation letter is issued by PDA. Should youattend a course without a formal confirmation orreceipt of payment you will be required toprovide a credit card as guarantee of payment.

Payment Options Group Registration: Register 4 people from the same organizations and the same site as a group for the conference and receive the 5th

registration FREE.

By Credit Card (American Express, MasterCard, VISA, Diners Club) clearly indicating account number and expiration date and billing address.Please bill my: American Express MasterCard VISA Diners Club

Total amount:

Card Number Exp. Date

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CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allowone week for receipt of confirmation letter. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. Emails are not accepted. If you are an unpaid registrant and do not attend the event, you areresponsible for paying the registration fee at the on-site registration rate if your cancellation has not been received in writing. Refunds for Conference/Event: If your written request is received on or before September 17, 2007, you will receive a full refund minus a $100 handling fee. After that time, no refunds will be made. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. Refund for Courses: If your written request is received by September 26, 2007 you will receivea full refund less a $200 processing fee. After that time, no refunds or credit approvals will be made. EVENT CANCELLATION: PDA reserves the right to modify the material orspeakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund.PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

Special Dietary Requirements (Please be specific)

* Registration fee includes a one-year PDA membership. No additional payment is required. If you do not wish to become a member, please check here

** Must be a PDA member to receive this rate.

Government/Member Nonmember* Health Authority Academic**

PDA #417: Visual Inspection (Oct. 17-18) $2,295 $ 2,695 $ 950 $ 950

* Registration fee includes a one-year PDA membership. If you do not wish to become a member, please check here ** Must be a PDA member to receive this rate.

3 Training Course October 17-18. Please check appropriate fee (US$).

PDA Federal Tax I.D. #52-1906152

Please note: In order to receive the discounted registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Register bySeptember 17

and save!

October 15-18, 2007Bethesda, Maryland

ConferenceOctober 15-16

Exhibition October 15-16

Course October 17-18

PDA Global HeadquartersBethesda Towers4350 East West Highway, Suite 200Tel: +1 (301) 656-5900Fax: +1 (301) 986-0296www.pda.org

conference exhibition course - midnight sun design knapp. research ... packaging materials, such as...

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