Tuesday, April 26, 2011
Utilizing Virtual Suppliers: How Manufacturers Can Develop a Compliant Virtual Supplier Program
In early 2010, Congress sent the FDA a letter detailing its concerns about how they were not adequately overseeing the industry’s use of suppliers. The letter particularly focused on suppliers that are "virtual" companies.
These suppliers have no physical, brick-and-mortar facility. Since the Heparin scandal, involving incompliant virtual suppliers, the FDA has increased its scrutiny of the supplier qualification processes. Now, manufacturers must prove that the virtual suppliers you utilize are a compliant piece of your supplier program.
Last year, John Avellanet, based on his decades of working in and with virtual suppliers, taught officials from the FDA and Health Canada the essential elements of an effective virtual supplier selection, qualification and oversight program.
Now is your chance to get a look at some of the same information that was given to FDA directors and inspectors. During this webinar, you will learn what the FDA expects of manufacturers who use virtual suppliers.
In 90 minutes, you will learn:
- Key components of a virtual supplier program that FDA inspectors will expect manufacturers to know
- What to do when on-site supplier audits are not an option
- What metrics can show the FDA that you are effectively monitoring your virtual suppliers
- How common industry practices from last century will get you in trouble today
- Red flags to be aware of: How to integrate check points into your processes
For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with Mr. Avellanet when we open up the phone lines for live Q&A.