Top 10 Life Science Company Audit Failures

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After countless Audits worldwide over the past 30+ years, Bob has comprised a list of what he sees as the Top 10 Audit Failures. No matter what the Audit platform (vendor qualification, FDA Validation, GxP Compliance, Pre-Market Compliance, Post-Market Compliance, Quality Management Systems, IT or Cloud Compliance), there are significant reoccurring themes that continue to plague pharmaceutical companies' processes. Come hear more about the top 10 recurring audit observations.

The presentation will include:

  • Discussion of top 10 recurring audit failures
  • Most frequently asked questions
  • Answers to your specific questions

 

About the Presenters

Rob Lesnefsky 3Robert (Bob) Lesnefsky, Global Vice President of Quality Assurance, Regulatory Compliance and Auditing at USDM Life Sciences

Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance, Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. As a GMP/DEA compliance expert, he provides compliance auditing, consultations, interpretations and remediations of cGMP for Manufacturing, Operations, Quality and Client Services to ensure the compliance of drug production and medical device manufacturing.

 

Bob Lucchesi 3Bob Lucchesi, Global Vice President of Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences

Bob is a Global Vice President of Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 25+ years of experience in quality assurance and regualatory compliance in pharmaceutical, biotechnology, medical device, engineering and nuclear industries. As a SME and Senior Auditor for USDM he provides expertise in Quality & Auditing, Enterprise Quality Management, Enterprise Content Management (ECM), and Governance, Risk & Compliance (GRC) Practices.

 

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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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