System Based FDA Inspection Readiness

In the fall of 2004, the FDA began using a risk-based approach for prioritizing domestic manufacturing site inspections for certain human pharmaceuticals. FDA Inspections, using the system based approach, evaluate how well senior management articulates their vision of quality to all levels of the organization.

One of the investigator’s primary goals is to assure communication to and training for personnel and contractors (as applicable) is performed and well documented. Per the understanding of an FDA investigator, the Quality System seeks to ensure that managers support the objectives with necessary resources and have measurable goals that are monitored regularly.

Another investigator goal is to tie quality system failures to gaps in the quality system. Where FDA regulations require establishment of procedures, and they are not present, there is the potential for regulatory observations. This presentation seeks to provide guidance on the FDA’s System Based Inspectional Approach, make recommendations on SME Do’s and Don’ts and provide guidance on how to prepare and stay ready.

MS Teams links to sample FDA System Based Pharma Inspection gap analysis tools will be provided following the presentation.

Mitchell Wheeler - PharmEng Senior Quality Consultant will be sharing his vast knowledge of the Audit/Inspection process of the FDA, answering the following questions:

What is the primary goal of and FDA Inspection?

How can you prepare for an FDA Inspection?

How does the FDA determine if personel is trained to operate within the quality system?

How does an Investigator tie quality system failures to gaps in the quality system?

Mitchell Wheeler is a 33 year healthcare industry manufacturing professional with experience in operations, engineering, supply chain, compliance, quality assurance, which includes 11 years of consulting. His experiences include sterile and solid dose pharmaceuticals, biologics, combination products, medical devices (disposable, serialized and IVDs), supply chain mgt and nutritional product manufacturing.

He has supported FDA GxP, MHRA, MCA, ANVISA, TGA, EU MDR, ISO, MDSAP, DEA, NRC, OSHA, VAWD, State Board of Pharmacy, as well as other types of compliance inspections. Mitch is also a skilled quality improvement professional, facilitator, investigator, quality tools user, project manager and cross functional collaborator who has supported teams on the development of improvements.

He holds MS and BS Degrees in Manufacturing Technology from East Carolina University and North Carolina A&T State University, respectively. During his career, he has earned certifications as Quality Manager/Organization Effectiveness, Quality Auditor, Biomedical Quality Auditor and Pharmaceutical GMP Quality Professional through the American Society for Quality (ASQ).