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Laboratory Inspection Readiness – Implementing GMPS for the Pharmaceutical Laboratory

 
  October 30, 2012  
     
 
ComplianceOnline, Online Event
2012-12-06


Why Should You Attend:

This laboratory inspection course is designed to provide participants with an understanding of the areas which are likely to be the subject of a laboratory inspection, whether it is a Pre-Approval Inspection or a general GMP inspection. By understanding the expectations, the participants will be able to develop a strategy to minimize issues should their laboratory be inspected.

Upon completion of this course the participant should:

  1. Be familiar with the areas in which regulatory inspectors are likely to probe.
  2. Be aware of the general expectations for each of these areas.
  3. Develop an overall strategy to minimize the likelihood of issues arising during an inspection.
Due to the diverse interests of the participants, questions will be actively solicited and addressed by the end of the webinar.

 

Areas Covered in this Webinar:

  1. Types of Inspections.
  2. Personnel Organization and Records.
  3. Instrument Inventory, Qualification and Change Control.
  4. Key SOPs Every Lab Should Have, and Related Training and Maintenance.
  5. Log of Out of Specification Results.
  6. Documentation of Analytical Procedures, including Validation, Verification and Change Control.
  7. Documentation of Analytical Data and Reports.
  8. Trending of Analytical Data, Laboratory Incidents and OOS Reports.
  9. Brief Introduction to Expectations for Computer Systems.
  10. Attendee Questions and Answers.

Who Will Benefit:

  • Chemists
  • Laboratory Managers
  • Regulatory Affairs
  • Quality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspection
  • IT/IS
  • Documentation
 
 
Organized by: Complianceonline
Invited Speakers:

Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using 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 pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances 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.


 
Deadline for Abstracts: 2012-12-05
 
Registration:

 For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702534?channel=hummolgen 

E-mail: referral@complianceonline.com
 
   
 
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