Quality Assurance and Quality Risk Management for Drug Importers

Instructor: Arvilla L Trag
Product ID: 701293
  • Duration: 60 Min

recorded version

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

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


Read Frequently Asked Questions

This Quality risk management training/webinar will examine considerations for the expanded role of QA in drug imports, and the expanded scope of Quality Risk Management with reference to FDA Globalization Act of 2009.

The FDA Globalization Act of 2009 will significantly impact the role of QA and the scope of Quality Risk Management. Prospective source audits and Quality Agreements will be required by the FD&CA. This presentation will examine considerations for the expanded role of QA in drug imports, and the expanded scope of Quality Risk Management relating to drug imports. The potential impact on CMOs, Quality Agreements, and drug pipelines will be discussed.

Areas Covered in the seminar:

  • QRM requirements added to the FD&CA.
  • Assessing current and prospective CMOs to determine their status vis a vis the new legislation / guidance.
  • Adapting Quality Agreements for the new QRM requirements.
  • The expanded role of QA in the Supply Chain.

Who will benefit:

This webinar will provide recommendations for QA and QRM compliance with the new legislation and guidance. It will benefit drug companies that use ex-U.S. CMOs, as well as companies that use CMOs in the U.S. The employees who will benefit include:

  • QA personnel
  • Risk Assessment staff
  • Regulatory personnel
  • Consultants
  • Supply Chain managers

Instructor Profile:
Arvilla L. Trag, RAC, ASQ-CQA holds a B.A. in Biology /Chemistry is Regulatory Affairs Certified since 1994 and an ASQ Certified Quality Auditor since December 2008. After working on the research bench for six years and then working in Regulatory Affairs and Quality Assurance for various small biotech companies for several years, Ms. Trag formed Midwest Consulting Services, Inc. in 1997, specializing in outsourcing and CMC compliance. In addition to conducting GMP audits and several GLP audits each year, she does GMP training, prepares Quality Agreements, develops Quality Systems for start-ups and virtual companies, and prepares INDs, BLAs and other regulatory submissions. Ms. Trag works with both biotech products and small molecule products, and also combination products.

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