In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.
Why should you attend:
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session:
Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
Who will benefit:
Pharma e.g. Pfizer, Roche, GSK; Biotech e.g. Genentech; Medical Device e.g. Medtronic, Stryker; CROs e.g. Covance, Quintiles, Theorem etc… Especially useful if you have received a 483 or warning letter; Food; Veterinary; CosmeticsTarget Companies:
Duration: 90 Minutes
Group of 3 to 5
Group of 6 to 10 + DVD-USB
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry. More recently, Ms. Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ and is working with the FDA to define those metrics that will be used for compliance at the Boardroom level. She is also assisting the FDA with updating their guidance "General Principles of Software Validation" (published in 2002)