ResearchBib Share Your Research, Maximize Your Social Impacts
Sign for Notice Everyday Sign up >> Login

2021 - FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Date2021-05-20 - 2021-05-21


VenueVirtual Seminar, USA - United States USA - United States

KeywordsFDA audit seminar; Quality assurance practices; Internal audit


Topics/Call fo Papers

Day 01(9:00 AM to 5:00 PM EDT)
Review of Regulatory requirements for the quality organization within companies. Will examine current FDA (21 CFR parts 210-211 and 820), EU and Health Canada requirements.
Discuss the importance of audits as a means of assuring compliance and the ability of the Quality System to meet its responsibilities.
Review importance of internal and vendor audits and provide a checklist of items to be covered and reviewed. Discuss expectations for applicable procedures covering these topics.
Discuss audit techniques that will help assure successful results when preparing for audits.
Review current industry guidelines for the investigation of "Out-of-Specification" (OOS) laboratory results.
Review current FDA Guidance document dealing with data integrity and issues that companies should implement.
Day 02(9:00 AM to 5:00 PM EDT)
Discuss areas of concern and focus during laboratory audits.
Review importance and requirements for personnel training.
Discuss current concerns by FDA and EU auditors regarding "operator error" when listed as the "root cause" for deviation investigations.
Review importance and requirements for vendor evaluations and quality agreements. What to look for, what to be included, etc. Discuss actual case studies as to actions taken by vendors and their potential impact on component, service or product quality.
Discuss importance of CAPA process and change control programs that help maintain compliance and prevent occurrences of deviations.
Review the 10 most common drug GMP deficiencies cited by the FDA inspectors during 2015-2016. Learn what quality systems are found most deficient.

Last modified: 2021-04-21 22:13:26