This “FDA Globalization Act” training/webinar will review the proposed legislation and guidance, the implications of each, and suggest approaches to proactive compliance in FDA Globalization Act of 2009.
The FDA Globalization Act of 2009 is legislation that will amend the FD&CA, and give significant teeth to the proposed Good Importer Practices guidance. As it is estimated that > 80% of APIs are imported into the U.S., the financial and manpower impact on the Pharma industry will be significant. This presentation will review the proposed legislation and guidance, the implications of each, and suggest approaches to proactive compliance.
Areas Covered in the seminar:
- Background on the legislation and guidance.
- Salient points of the FDA Globalization Act of 2009.
- How the definitions of "misbranded" and "adulterated" will change.
- The four guiding principles of the proposed Good Importer Practices guidance .
- Specific implications for industry, including expanded regulatory responsibilities.
- Specific implications for pharma relationships with ex-U.S. CMOs.
Who will benefit:
This webinar will provide valuable information to pharmaceutical and biotech companies that import APIs, bulk drug products or final products from outside the U.S., as well as companies that use CMOs within the U.S. It will also benefit CMOs inside and outside the United States. The employees who will benefit include:
- Supply Chain managers
- Regulatory personnel
- QA personnel
- Consultants
- Customs house brokers handling drug imports
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.
