FDA's Quality Metrics - Latest Advances


Thursday, March 14, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 90 Minutes          

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Duration: 90 Minutes  

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This is a very important webinar for the FDA who is planning to use the quality metrics as part of their risk based inspection process.

Angela Bazigos   Product Id : 502351
  Instructor : Angela Bazigos

  More Trainings by this Expert


Overview:

This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Why should you Attend: This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk based inspection process. Consequently, putting the quality metrics program in place may reduce the inspection frequency at your facility.

Areas Covered in the Session:

  • FDA Centers involved in Quality Metrics
  • The Issue
  • Draft Guidance for Industry: Request for Quality Metrics
    • Background
    • Covered Drugs and Establishments
    • Quality Metrics FDA intends to calculate
    • Optional Quality Metrics that may be submitted
    • How FDA intends to use quality metrics
    • Sections indicated for public comment
  • FDA public meeting
  • FDA Public Meeting results
  • What about CDRH?
  • References

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • GxP
  • Consultants
  • Quality VPs
  • IT VPs


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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