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The Hitchhikers guide to 483s and Warning Letters

Tuesday, May 21, 2013 Duration : 90 Minutes 10:00 AM PDT | 01:00 PM EDT Speaker | Angela Bazigos

To register for this webinar please visit our website www.compliancetrainings.com

Webiar Description:
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Areas Covered in the Session :

> FDA Inspections - Background > Causes of Form 483 / Warning Letter > Some recent results of companies failing to respond appropriately > Best Practices for Responding to 483 > Best Practices for Responding to Warning Letter > What to do if the responses fail

Who Will Benefit:

> Regulatory Affairs professionals > Quality Managers > Quality Engineers > CEO > Regulatory VP > Quality VPs > IT VPs > Small business owners > GxP > Consultants To register for this webinar please visit our website www.compliancetrainings.com

Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in life science. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored Computerized Systems in Clinical Research with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanfords Whos Who for contributions to the Life Sciences industry.