ComplianceOnline

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

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$329.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.

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

Instructor Profile:

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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading