This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations. Use of statistics has been part of the FDA’s guidance and regulations for many years. Use of statistical tools is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. Learning Objectives : To have a complete understanding of what the FDA is requiring pharma and biotech companies to do regarding the use of statistical thinking and methods and what statistical concepts, methods and tools that can be used to satisfy the FDA requirements. Key Take Away : Awareness and understanding of what the FDA is looking for in the use statistics Understanding of what works and doesn’t work Obtain information and ideas on approaches that have worked in a variety of situations Areas Covered in the Session : Today’s Reality: FDA Guidance Regarding: Quality by Design Continued Process Verification Test Method Development FDA Guidance’s – Examples of Recommended use of Statistical Thinking and Methods Tools, Methods and Personnel What is the Appropriate Documentation? What’s the FDA Looking for? Right Process Measurement, Data, Tools and Methods and Interpretation Useful Standards Understanding of tool usage and interpretation of results Tips, Traps and Recommendations Who Should Attend: Executives and Managers of Pharma and Biotech Companies Process and Manufacturing Engineers Quality Assurance Personnel Regulatory Affairs Professionals Quality Control Lab Personnel Quality Engineers Research and Development Scientists Biologists and Microbiologists Chemists and Chemical Engineers


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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