Essential Tips for Outsourcing 21 CFR 11 Compliance at Critical Suppliers| July 22, 2014, 2-3:30 PM EST | Avellanet
February 27th, 2014 // 3:03 pm @ jmpickett
Why You Should Attend
FDA’s mantra for the past few years has been “more supplier scrutiny and more enforcement of Part 11.†Between the rise of cloud computing, more outsourcing, and growing use of contract manufacturers and outsourced clinical trials, pharma and device firms are stuck between FDA’s special enforcement and rapidly changing business models.
The result has been a rise in FDA-483s and warning letters like this to Replidyne:
• “…submitted data from several clinical investigative research sites in support of NDA [ ] but did not adequately verify the integrity of that data, prior to submission to FDAâ€
Or this warning letter to Cincinnati Sub-Zero Products:
• “Failure to establish and maintain adequate procedures for validating the device design, including software. The software used in the microprocessor boards [provided by a supplier]…has not been validated.â€
Will FDA believe your suppliers are providing Part 11 compliant services and data?
A supplier’s data integrity increasingly plays a critical role in proving your compliance and proper oversight of purchased materials and services. For clinical trials, FDA will delay or even deny a submission when it perceives that trial data is untrustworthy.
Learn how FDA is enforcing 21 CFR 11 today, how it applies to your critical suppliers, and how to put in place a cost-effective, risk-based Part 11 oversight program today. Learn the SOPs and policies to have, how to incorporate risk assessments, and how to tackle suppliers such as CROs, CMOs and hosted IT providers who maintain regulated records on your behalf.
Attendees will receive practical and easy-to-use information that converts warning letter cautions, FDA official statements, and investigator questions into real-world experiences, best practices and valuable benefits.
Areas Covered In the Webinar
- How 21 CFR 11 (“Part 11â€) inter-relates with other FDA regulations
- FDA’s view of “critical†suppliers – who’s in and who’s out when it comes to Part 11
- Types of supplier-provided data FDA reviews under its Application Integrity Policy
- List of sampling methods FDA will accept when reviewing supplier-provided data
- Elements of a supplier-provided computer validation protocol that FDA will accept
- Red flags that indicate a supplier’s data integrity is failing
- Records you need to prove to FDA that your supplier Part 11 oversight met expectations
- FDA concerns around your oversight of a supplier’s computer validation activities
- Tips for when you are planning to outsource production and/or clinical testing
- How to handle IT hosting suppliers that maintain your data in their data center
- SOPs and policies you need to have
Free documents/Article/ebooks/SOPs/checklists for Attendees
- Checklist of core Part 11 controls points to answer when qualifying a supplier
- Checklist of critical elements to review in a supplier’s computer validation plan
Who Should Attend?
FDA-regulated companies including:
• medical device firms
• pharmaceutical firms
• biotechnology firms
• OTC cosmetic firms
• contract research organizations (CROs)
• contract manufacturing organizations (CMOs)
and IT companies that provide computer, software/programming services to the above.
Instructor Profile
John Avellanet is an award-winning expert and internationally renowned speaker on cost-effective FDA compliance. He was trained to conduct FDA Part 11 inspections by several of the authors of 21 CFR 11. And he spent 15 years personally accountable for regulatory compliance, data integrity, supplier management, and records litigation support, most recently as a C-level executive in a combination biopharmaceutical and device Fortune 50 subsidiary.
Since founding his independent lean compliance FDA consulting firm, Cerulean Associates LLC, he’s traveled around the world helping clients and solving problems with practical, innovative solutions to strengthen compliance while lowering costs and reducing risk.
Over the past seven years, Mr. Avellanet has been interviewed on multiple public radio programs and media podcasts. His most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011.
He was the lead author for the two US RAPS supplier quality management certification courses, and in 2011, Mr. Avellanet was selected by the US Department of Health and Human Service OIG to oversee a multi-million dollar medical device corporate integrity agreement.
Winner of the 2009 & 2011 Best of Business Services award by the US Small Business Commerce Association, Mr. Avellanet has earned international acclaim for his business-savvy, pragmatic FDA compliance advice.
