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Responding to an Audit Failure, FDA Warning Letter or Investigation

Like so many regulated firms, you may have received findings, observations, a warning letter, or 483 from either an outside audit, registrar, or regulated agency such as the FDA. Don’t panic! There are steps you can take to mitigate the process and become compliant by addressing each one in a planned and organized manner. This webinar will highlight those steps and take you through the process from planning to implementation.

The presentation will include:

  • Proper planning
  • Initial responses
  • Selecting the right resources
  • Execution and Implementation of Remediation
  • Maintaining Compliance
  • Validation process and procedures
  • Live Q & A session

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 regulatory 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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