Conducting Effective Mock FDA Inspections
Instructor:
David L Chesney
Product ID: 706913
- Duration: 90 Min
Why Should You Attend:
This webinar will compare GMP audits and mock regulatory inspections, explaining the differences to take into consideration when planning a mock regulatory inspection. The webinar will focus primarily on FDA inspection readiness, but the concepts are applicable regardless of which regulatory venue you are preparing to host.
Areas Covered in the Webinar:
- Comparison of a mock inspection to a standard GMP audit
- Points to consider in planning a mock inspection and selecting the mock inspector
- Goals of a mock inspection versus a standard GMP audit
- Preparing subject matter experts to be interviewed during a mock inspection
- Where to find helpful online resources from the FDA, EMA and other agencies to assist your inspection readiness efforts
Who Will Benefit:
- Senior leadership team members
- Quality Assurance staff
- Company auditors
- Regulatory Affairs personnel
- In-house legal counsel
- Any staff who coordinate and manage mock inspections
- Anyone seeking to understand how mock inspections can help with inspection readiness efforts
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.
More Training By Experts
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
