Integrating Pharmacovigilance and Technical Complaint Systems

Speaker

Instructor: David L Chesney
Product ID: 704956
Training Level: Intermediate

Location
  • Duration: 90 Min
This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP
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Why Should You Attend:

In many companies, pharmacovigilance (drug safety) and technical complaint systems are seen as separate functions, and while some overlap may be recognized, these systems are often not well integrated, resulting in failure to identify correlating issues and resultant regulatory compliance risk.

This webinar examines the FDA requirements for pharmacovigilance and for complaint evaluation under GMP, and how they overlap and impact one another. Suggestions for integrating these activities to derive benefit and minimize regulatory risk are presented.

Learning Objectives:

  • Understand GMP requirements for complaint investigation
  • Understand drug safety reporting requirements
  • Appreciate the interrelationship of these two areas
  • Understand steps to take to coordinate the two areas and mitigate risk

Areas Covered in the Webinar:

  • GMP requirements for complaint investigation
  • Drug safety reporting requirements under 21 CFR 310.80
  • How these requirements impact each other
  • Risks of failure to recognize the interrelationship between these areas
  • Regulatory risks resulting from FDA inspection findings
  • Mechanisms for coordinating the two activities so as to mitigate risk

Who Will Benefit:

  • Quality Assurance managers
  • Personnel responsible for complaint investigation
  • Drug safety professionals
  • Regulatory Affairs professionals
  • Operators and staff of call centers who receive complaints and adverse event reports from practitioners, patients and others
Instructor Profile:
David L Chesney

David L Chesney
Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC. His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

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