Product Life-cycle Management Program for Process Validation: FDA’s Current Expectations | Oct. 25, 2013, 2 PM EST | Medina

Product Life-cycle Management Program for Process Validation: FDA’s Current Expectations | Oct. 25, 2013, 2 PM EST | Medina

September 25th, 2013 // 9:14 pm @

Process Validation and on-going verification is a continuous process calling for a planned life-cycle management program to ensure that the manufacturing process remains capable and in a state of control. This is achieved through the systematic compilation, analysis, and assessment of process-related data, anddeep understanding of actions taken during a product’s manufacturing history.

This 90-minute session will provide step-by-step methodology to help companies designa sustainable Product Life-Cycle Management Approachagainst a backdrop of FDA’s current process validation expectations and regulatory trends.Attendees can expect to explore a meaningful life-cycle approach for both new and legacy products.

What You Will Learn

  • Process Validation as a Product Life-cycle Management Program: What does it really mean and why it works
  • FDA’s Written and Unwritten Expectations: Industry trends and Impact of new FDASIA Legislation; FDA 2011 Guidance for the Industry and CPG Sec. 490.100
  • Prerequisites for a Validation Product Life-cycle Management Approach: Infrastructure requirements
  • A Three-phase Approach to Establishing a Meaningful and Sustainable Program

Complete Process Validation Webinar Outline

I.  Process Validation as a Product Life-cycle Management Program

  • Why this works
  • FDA’s written and unwritten expectations
  • Industry trends
  • Trending programs and how they impact your process

II. Preparing for the Future

  • Pre-requisites for a validation product life-cycle management approach
  • Old versus new products – where to begin
  • Synergize with risk assessment activities
  • Infrastructure requirements

III. Defining the Beginning and the End 

  • What should be monitored and why
  • Value drivers
  • Risk trending
  • Recontextualize management mindsets

IV. Key Drivers for FDA Compliance

  • Current FDA trends
  • Regulatory overview
  • FDA 2011 Guidance for the Industry
  • CPG Sec. 490.100

V. Measuring Success 

  • The Quality Triad
  • The GEM Planâ„¢
  • Establishing alert & action limits


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 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.

Number of Attendees

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