Select Industry Training Type

Select Month Select Location Select Speaker Search Site Search GO

Bookmark Add To Calendar 6

Speaker : Gregory MartinGregory Martin, is President of Complectors Consulting which provides consulting andtraining in the area of Pharmaceutical Analytical Chemistry. He has particular interest inQbD/Lean approaches to dissolution testing, impurity methods, method lifecycle(development/validation/transfer) and instrument qualication, and is passionate aboutusing good science and sound logic to achieve high quality results, consistent with cGMPs,while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceuticalindustry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMAcompany for a number of years. In addition, he has volunteered for the USP for over 10years, and currently serves as Vice Chair of the General Chapters Physical AnalysisExpert Committee, and serves on Expert Panels on Validation and Verication, Weights andBalances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on theEditorial Advisory Board of the Journal of Validation Technology and Journal of GXPCompliance

more...

Effective Investigation of Out of Specification, Out of Trendor Atypical Results

Course Description:This course is designed to provide sound training on how to recognize and address atypical orout of specication results, using approaches which have been recommended by regulatoryauthorities, performing appropriate investigations.Course Objective:

Be familiar with various terms associated with investigations of atypical or out ofspecification results, and how to document those investigations.Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specication(OOS) Test Results for Pharmaceutical Production and how to apply it in laboratorysituations.Be able to create a Laboratory Investigation Checklist and eectively document aninvestigation, including rationale and results.Know the importance of Corrective and Preventative Action (CAPA) and be able toidentify appropriate CAPAs.Understand practical strategies to utilize outcomes from investigations for continuousimprovement and reduction of future OOS results.

Course Outline:

Topic ID : 485 Duration : 120 Mins

Attend Live Webinar16-Sep-2014 : 10:00 AM PST

$ 229.00 Single Attendee $ 749.00 Group Max 10 Attendees perlocation (For multiple locations contact Customer Care)

$ 279.00 Access Recorded Version online Available for one viewer for 6 Months (For multiple viewers, please contact Customer Care)Recorded Link and Reference material will beavailable in My Account Section, 48 hrs aftercompletion of Live training

$ 349.00 Buy Training CD-DVD CD-DVD is meant for single location use.(For multiple locations, please contact Customer Care)Recorded CD-DVD will be despatched after 72 hrs oncompletion of Live training

Buy NowBuy Now Refund Policy

ShareShareShareShareMore

TOLL FREE: +1-866-978-0800

Webinars Seminars Products News & Resources Our Experts About Us Contact Us Cart (0)

Sign In Sign Up

Created by PDFmyURL. Remove this footer and set your own layout? Get a license!

1. Basis for QualificationCalibration and qualication of equipment requirements in GMP guidelines for FDA andEMAUSP General Chapter Analytical Instrument QualificationUSP General Chapter Dissolution refers to Performance Verification Test

2. Approaches to Dissolution Instrument QualificationMore challenging due to chemical, physical and temporal factors affecting resultsMechanical specifications available for vessels, stirring units and assembled instrumentUSP Reference Tablets allow holistic evaluation of apparatus

3. Recent ChangesFDA Guidance and FIP Position Paper on Mechanical QualificationUSP changes in acceptance criteria from individuals to mean and RSD

4. Common PitfallsTrainingDeaerationVibrationVessel geometryProcedure details: filter qualification, dropping tablets, etc.Responding to failures

5. RecommendationsMake informed decisions about how instruments will be qualified, and by whomTrainingDocument detailed procedures, methods, response to failures

6. Attendee questionsTarget Audience:Chemists, Supervisors and Managers in Pharmaceutical Laboratories and Quality AssurancePersonnel responsible for generating or evaluating test results in a regulated environment.

Similar TrainingsUSP Hot Topics: Whats Hot Now and How to TrackComing Changes and Influence USP WebinarLive : Scheduled on 14-Oct-2014 : 10:00 AM PSTHow to approach organizational changemanagement when automating processes thatrequire FDA complian...Live : Scheduled on 17-Sep-2014 : 10:00 AM PSTClassification of systems (GAMP5) to develop anappropriate validation approachLive : Scheduled on 24-Oct-2014 : 10:00 AM PSTQualification Sample Size and Statistical Confidencefor Pharma Process Performance QualificationLive : Scheduled on 26-Sep-2014 : 10:00 AM PST

More Trainings By : Gregory MartinNo Similar Training(s) Found by Author

Previous Trainings By : Gregory MartinConducting Effective Investigations of Out ofSpecification and Atypical Laboratory ResultsLaboratory Inspection Readiness - ImplementingGMPs for the Pharmaceutical LaboratoryDissolution Instrument Qualification to MeetRequirements and Minimize Product OOSDissolution Resul...Control of Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents,Elemen...

About UsTestimonials

About UsPharmaceuticals Biotechnology

IndustriesRecorded WebinarsCD/DVD

Product & Services

Complianz News

News &Resources

Contact UsTOLL FREE: +1-866-978-0800FAX: +1-888-883-7697

Created by PDFmyURL. Remove this footer and set your own layout? Get a license!

Contact Us

Terms of UsePrivacy PolicyDisclaimerRefund PolicyAdvertise / Sponsor

LegalMedical DevicesFDA ComplianceClinical ResearchLaboratory ComplianceHealthcare ComplianceBFSIHuman Resources (HR)OSHATrade And LogisticsGRC

ArticlesWhitepapersMarket Reports

LIVE SUPPORTREQUEST A CALL BACK

Subscribe to ournewsletterSubscribe to our newsletter andget industry updates along withexclusive deals on relatedtrainings

Subscribe

100% Secure Payment (PCI DSS)

Payment Processing

We Accept Connect With Us

2013 - Complianz World. All Rights Reserved.Use of this Web site constitutes acceptance of the Complianz World Terms of Use and Privacy Policy. Leave A Message

Created by PDFmyURL. Remove this footer and set your own layout? Get a license!