Falls Church, VA (PRWEB) November 20, 2013
For the attendees in the room, getting first-hand insight from their 44 years of experience was a goldmine. Now devicemakers can have that goldmine too.
Announcing — The Insider’s Guide to Supplier Quality Success: FDA Device Experts Reveal Their Secrets
Here are a few of the questions attendees asked…and got answered.
This 2-DVD package includes:
1. Why outsourcing should equal more—not less—work for your quality management staff;
2. Best practices in quality process validation and change control—vendors that change their source materials, specs or processes willy nilly are a recipe for disaster;
3. CAPA, CAPA, CAPA—problems happen, and the FDA will find them; it’s how you’ve structured a feedback loop to ensure they are detected, investigated, corrected and monitored that counts;
4. Examining incoming materials and components to make sure you’re getting what you asked for—no, not all screws are the same.
True subject matter experts to effectively guide devicemakers:
This DVD presentation was created for FDAnews by Martin Browning, President and Co-Founder, EduQuest; and Janis Olson, Vice President of Quality and Regulatory Services, EduQuest. Both are former FDA inspectors.
Browning’s 22-year FDA career included work as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, he chaired the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).
Olson worked at the FDA for more than 22 years, conducting domestic and international inspections. She capped her agency career as the Director of the Information Resources Management Office in FDA’s Southeast Region. Currently she helps EduQuest clients comply with GxP regulations and apply risk management concepts and tools to meet FDA’s expectations and international standards. She also helps clients prepare for FDA inspections through training, writing and updating SOPs, and reviewing computer validation documentation.
One low price of $797 includes all the materials described above. Order now to reduce supply chain risk and enhance profitability.
Easy Ways to Order
By phone: 888-838-5578 or 703-538-7600
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