How to Prepare for a Regulatory Inspection

On-Demand Webinar

Are you faced with an upcoming or potential regulatory audit? This webinar will help you prepare for a Pre-Approval Inspection (PAI) by showing areas that are typically missed and turn into a finding.

This webinar will also cover the ISO 9001:2015 update for companies that are thinking about ISO certification as well as companies that have 2008 and want to move to 2015.

The discussion will include:

  • Proven step by step strategies for preparedness
  • Required and suggested documentation for both PAI and ISO
  • Real life examples of inspections and results
  • Live Q & A session

About the Presenters:

Diane Gleinser 85x105 rightDiane Gleinser is the Senior Vice President of Life Science Services and Solutions at USDM Life Sciences. Diane has more than 27 years of experience in life science based industries, encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.

 

Bob Lucchesi 3Bob Lucchesi is the Vice President of Global Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences. Bob offers nearly 30 years of experience in quality assurance and regulatory compliance in pharmaceuticals, bio-tech, medical device, engineering and nuclear industries. Bob has led audit teams for Quality, mock FDA, policies and procedures, Part 11, NIST, supplier-vendor (internal, external, sterile, non-sterile, manufacturing, logistics), mock recalls, and major life sciences assessments. Bob is also an expert in risk based validation methodologies, GAMP, enterprise content management, data and content migrations as well as overall pharmaceutical and medical device regulatory issues.

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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