E17: Update on New Analytical Requirements of USP General Chapters

One-Day Course

Mr. Gregory Martin, Complectors Consulting, Pottstown, PA

COURSE DESCRIPTION
This one-day course will provide some insight into some of the hottest topics at USP, which will have the greatest impact on pharmaceutical laboratories:  Elemental Impurities, Validation and Verification, Residual Solvents, and Organic Impurities.  We’ll also provide some strategies for keeping abreast of future changes using USP’s free publication announcing anticipated changes, and how you can influence USP with your comments and concerns.

WHO SHOULD ATTEND

  • Quality Control and R&D Scientists in Pharmaceutical, Generic or Contract Lab Organizations
  • Laboratory Supervisors and Managers
  • Quality Assurance, GMP Auditors, CMC or Regulatory Affairs personnel

TOPICS
1. Hot topics at USP
     * Elemental Impurities:  Major changes coming, effective in 2018 
     * Validation and Verification:  Lifecycle approach proposed; new statistical chapter <1210> 
     * Residual Solvents:  Changes in USP <467> provide clarity, flexibility 
     * Organic Impurities:  USP finally adopts ICH Q3A and B!

2. Pharmacopeial Forum
     * USP’s tool to announce coming changes 
     * It’s FREE to access! 
     * You opinions are important!

3. Questions and discussion

ABOUT THE INSTRUCTOR
Mr. Greg Martin is 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 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, 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.  He is also Past Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.  Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.