Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

Duration: 90 Minutes
This 90 Min laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
GMPs for the Pharmaceutical Laboratory
Instructor: Gregory Martin
Product ID: 502048
Objectives of the Presentation
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
  • 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
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
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the 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 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 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 is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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