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:
Be familiar with the areas in which regulatory inspectors are likely to probe.
Be aware of the general expectations for each of these areas.
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 the Webinar:
Types of Inspections.
Personnel Organization and Records.
Instrument Inventory, Qualification and Change Control.
Key SOPs Every Lab Should Have, and Related Training and Maintenance.
Log of Out of Specification Results.
Documentation of Analytical Procedures, including Validation, Verification and Change Control.
Documentation of Analytical Data and Reports.
Trending of Analytical Data, Laboratory Incidents and OOS Reports.
Brief Introduction to Expectations for Computer Systems.
Attendee Questions and Answers.
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:
Be familiar with the areas in which regulatory inspectors are likely to probe.
Be aware of the general expectations for each of these areas.
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 the Webinar:
Types of Inspections.
Personnel Organization and Records.
Instrument Inventory, Qualification and Change Control.
Key SOPs Every Lab Should Have, and Related Training and Maintenance.
Log of Out of Specification Results.
Documentation of Analytical Procedures, including Validation, Verification and Change Control.
Documentation of Analytical Data and Reports.
Trending of Analytical Data, Laboratory Incidents and OOS Reports.
Brief Introduction to Expectations for Computer Systems.
Attendee Questions and Answers.
Speakers
Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.
He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing 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 is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.
