Earlier this year, 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?
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
- Excerpts from 15 warning letters and related exercise materials
- And… FDAnew’ Conducting Supplier Audits: A Guide for Medical Devicemakers management report (a $347 value)
Four Easy Ways to Order
Please mention priority code 13N06 when ordering.
- Order online.
- Call toll free 888.838.5578 (inside the U.S.) or +703.538.7600; Use your American Express, Visa, or MasterCard.
- Fax your purchase order to 703.538.7676.
- Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.
Source: FDANews