Effective Deviation Investigators Under GMP

Why Should You Attend:

Observations involving deficient investigations and CAPA systems repeatedly rank among the top three to five observations noted by FDA during inspections, year over year. Failure to perform effective investigations violates GMP requirements, puts patients at potential risk and results in regulatory risk exposure that is preventable. Knowing how to approach deviation investigations in GMP effectively not only minimizes compliance risk, it constitutes sound quality management practice and can reduce the recurrence of problems that can lead to batch rejections and financial losses.

Learning Objectives:

• Understand the GMP requirement for deviation investigations
• Learn why Out of Specification investigations are an important special case
• Learn the steps to take
• Learn what tools may help with the investigation
• Learn common reasons FDA cites companies for inadequate investigations
• Learn what makes a good deviation investigation report
• Learn the importance of follow through to ensure corrective actions have been effective and have prevented recurrence

Areas Covered in the Webinar:

• GMP requirement for deviation investigations
• Steps in an effective investigation
• Examples of investigative tools to assist with resolution of deviations
• Common problems and pitfalls in deviation investigation
• The special category of Out of Specification (OOS) investigations
• Writing good investigation reports
• Verifying corrective action and preventing recurrence

Who Will Benefit:

• Quality Assurance professionals
• Manufacturing professionals
• Laboratory managers and analysts
• Regulatory Affairs professionals

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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