Performing Effective Management Review of the Quality System
Instructor:
David L Chesney
Product ID: 704933
- Duration: 90 Min
Why Should You Attend:
Under FDA regulations, Medical device companies are required to perform at least an annual review of the quality system. Pharmaceutical companies are not required but are "expected" to do so in the U.S., and are required under certain non-US countries’ regulations. In addition, guidance documents from the FDA and industry groups encourage management review.
Management review can be burdensome and difficult if not planned to focus on the right metrics, and governed by an efficient process. This webinar explores a successful approach to the performance of management review that yields a value added result and helps gain the buy-in of the executive level whose support is needed.
Learning Objectives:
- Understand the purpose of management review
- Understand the regulatory requirement for management review
- Understand an effective process for conducting the review
- Understand documentation requirements
- Understand FDA policy regarding disclosure of management review information during inspections
Areas Covered in the Webinar:
- Regulatory requirements for management review
- Status of management review under US, European and Canadian GMP, US medical device QSR, and via ICH Guideline Q10
- Purpose of management review
- Process for an effective management review
- Documenting management review meetings
- FDA policy on access to management review documentation during inspections
Who Will Benefit:
- Quality Assurance managers
- Manufacturing managers
- Laboratory managers
- Regulatory Affairs managers
- Senior level executives
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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