Impact of FDASIA – New Quality Agreements Guideline, and Compliance Program Guide Sec. 490.100 for Process Validation | Aug. 7, 2014, 2 PM EST | Medina

Impact of FDASIA – New Quality Agreements Guideline, and Compliance Program Guide Sec. 490.100 for Process Validation | Aug. 7, 2014, 2 PM EST | Medina

May 1st, 2014 // 8:57 pm @

FDASIA is legislation signed into law on July 9, 2012 that amends several drug and device provisions of the FD&C Act. By specifically addressing Drug Supply Chain, it enhances FDA’s authority over a manufacturer’s supply chain while strengthening FDA’sadulteration laws. In addition, FDASIA increases FDA’s authority over registered and unregistered foreign firms. Most significantly, this new legislation increases FDA’s inspection authority and reaffirms 211.100 and 211.110 regulations.

Why You Should Attend

FDA’s newly published Quality Agreements Guideline, while not codified law, delineates FDA’s expectation that firms treat their suppliers as an extension of their own operations. Understanding FDA’s thinking with respect to supplier management is essential sustainable compliance and a successfulpre-approval inspection.

Last but not least is FDA’s new guidance to investigators related to process validation, which can be found in Compliance Program Guide Sec. 490.100. FDA’s expectation is that Process Validation be accomplished by employing a Product Life-cycle Management Program, which should address both new, and legacy products.

Attendees will learn more about each of these new FDA directives and how they can use these initiatives as part of their company’s risk management. The industry must prepare for the trickle down effect of new legislation, enhanced inspection muscle and supply chain focus.

What You Receive

With your order, we would like to offer you these six items at no added cost:

  • Powerpoint slides to share
  • Downloadable recording or CD
  • Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
  • Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
  • Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
  • Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00

About the Speaker

Carmen Medina oversees PCI’s consulting services for the West Coast BIO region and internationally from her San Diego office. She was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations—QSR. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.

Over the past 20 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands. She has also consulted with several vaccine manufacturing companies throughout the world, including The Salk Institute Biotechnology/Industrial Associates. Ms. Medina has helped numerous pharmaceutical, medical device and biologics firms with FDA inspection-readiness and specializes in risk management, compliance, quality assurance and regulatory strategy. Her unique approach to PAI-readiness has garnered PCI extensive accolades from both domestic and international companies for its support in the commercialization of medically needed products. She is editor of the textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, as well as numerous articles related to reimbursement, innovative approval pathways, and exit strategies for start-up and emerging biotech companies.


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