USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP
Instructor:
Gregory Martin
Product ID: 703521
- Duration: 90 Min
Why Should You Attend:
The United States Pharmacopeia (USP) is changing more rapidly than ever – are you keeping up? You need to be aware of the pending changes especially since USP is the standard-setting organization for the FDA with expectations that you will be in compliance.
This webinar will detail some of the areas with the most significant changes, and provide strategies for anticipating future changes.
Areas Covered in the Webinar:
- Hot topics at USP
- Analytical procedures: Validation, verification and transfer being replaced with method lifecycle
- Weighing on an analytical balance: General Chapters <41> and <1251>
- Elemental impurities: Major changes are coming, but the timing and limits are uncertain
- Overview of proposed or recently implemented changes
- Analytical procedures
- Basic lab tests
- Impurities
- Spectroscopy
- Dosage forms
- Packaging
- Dietary supplements
- How to anticipate or influence changes
- Pharmacopeial Forum
- You opinions are important!
- Questions and discussion
Who Will Benefit:
- Quality Control Personnel
- R&D Scientists in Pharmaceutical, Generic or Contract Lab Organizations
- Laboratory Supervisors and Managers
- Quality Assurance Personnel
- GMP Auditors
- CMC or Regulatory Affairs Personnel
Gregory P. 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 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.
More Training By Experts
- Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer
- Residual Solvents: Understanding the Requirements and Practical Advice for Implementing USP <467>/ICH Q3C
- Dissolution Instrument Qualification to Meet Requirements and Minimize Product OOS Dissolution Results
- 4-hr Virtual Seminar: Using the USP Effectively
- QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
