On June 6th, in a conference room in Bethesda, MD, two former high-ranking FDA veterans, Martin Browning and Janis Olson led a one-of-a-kind strategy session on how to create a bulletproof medical device supplier quality system.
For the attendees in the room, getting first-hand insight from their 44 years of experience was a goldmine. Now you can have that goldmine too.
Here are a few of the questions attendees asked…and got answered.
Is a company that only distributes a product without placing its name on the product responsible in the eyes of the FDA for problems with the product?
What do you do if a supplier refuses to share information about its sub-suppliers?
Do FDA inspectors expect documents from foreign suppliers to be translated into English?
Will the FDA inspect raw materials and components suppliers without cause?
How do you determine whether a product is a component or finished device?
In what cases might a supplier deny manufacturers access to its CAPA system?
This 2-DVD package includes:
A 50 minute introduction and overview from Martin and Janis on the importance of supplier quality, with an emphasis on the FDA’s current inspection trends and how to protect your company with comprehensive quality systems and supplier contracts.
250+ minutes of instruction on making sure your suppliers meet the same quality standards the FDA expects of you. Details include:
Why outsourcing should equal more—not less—work for your quality management staff;
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;
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;
Examining incoming materials and components to make sure you’re getting what you asked for—no, not all screws are the same.
25 minutes of audience discussion of 7 real-life Warning Letter scenarios, resulting in “here’s what should have been done differently” conclusions.
More than 25 minutes of Q&A focusing on real-world problems faced by attendees, with answers from Martin and Janis and fellow attendees.
Copy of the FDA’s Quality Systems Regulations (QSR)
Copy of the FDA’s Quality System Inspection Technique (QSIT)
200+ slide deck from the workshop
Excerts from 15 warning letters and related exercise materials
And… FDAnews’ Conducting Supplier Audits: A Guide For Medical Devicemakers management report (a $347 value)
True subject matter experts to effectively guide your organization
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.
One low price includes all the materials described above. Order now to reduce risk in your supply chain and enhance profitability.
Martin Browning, President and Co-Founder, EduQuest
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).
Janis Olson, Vice President of Quality and Regulatory Services, EduQuest
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.
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