An FDA Inspection Survival Guide with Jonathan Wacks

In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections.

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Jonathan is a medical device and pharmaceutical Consultant specializing in QA/RA and Product/Process Control. His services include M&A due diligence support, conducting site quality and regulatory compliance audits, and leading employee training programs focused on FDA QSR/cGMP and validation.

He also works in project management and operations improvement, particularly in research use diagnostics and API manufacturing. He's a regular and highly-valued contributor to our Insider Newsletter.

A few key discussion points include:

• The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments and preemptively identifying compliance issues underlining the need for thorough and honest internal evaluations.

• The need for leadership teams to understand audit findings in depth and use them to enhance internal processes.

• The importance of having well-calibrated and maintained test equipment, alongside well-crafted SOPs and trained personnel.

• The need for independent reviews of batch records, focusing on the clarity of lot status and data integrity.

• The need for regular reviews and updates of QMS processes, especially validation and verification procedures.

• The importance of re-evaluating product and process validation, including considerations for stability data, human factors, and the impact of significant changes.

• The critical role of software validation in the QMS.

• How to effectively handle questions from FDA investigators and the importance of clear, honest communication during audits.

Also, if you haven’t seen our discussion with former FDA investigator Chris Smith on PAI preparation, we definitely suggest a watch:

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