Audit Focus of the FDA | Kenneth Christie

Summary :
⁣All drug manufacturers, biotechnology, medical devices and cosmetic companies are subject to, and are routinely audited by the FDA, if your product is sold in the US. Getting through a regulatory audit is a combination or being both prepared and having an understanding of the approach used by auditors and what will be their areas of focus. In addition, the most common cited GMP deficiencies can provide companies with a roadmap as to how their own procedures and processes may stand up during such audits. This presentation will provide a highlight of what are the approaches used by regulatory auditors, what are the common areas of focus, and what are the answers and actions to avoid. Additionally, the most commonly cited GMP deficiencies during 2020, will be reviewed and discussed, such as insufficient or lack of investigations for deviations, data integrity, and a lack of defining the responsibilities of the quality unit, to name a few. Realizing that most companies do receive periodic deficiencies or 483s, the attendees will learn several tips as to how best to address the findings.


About Author :
⁣Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, supplier qualification, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. Mr. Christie is a speaker and trainer for several professional organizations and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.