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How to Prepare for a FDA Regulatory Audit - the Dos and Don’ts
- Regulatory expectations that deal with auditing
- Checklist of items that auditors are expected to review
- Training for performing and handling audits- what to look for, what to do and not do
- How best to evaluate audit findings
- Recommendations for how best to address FDA audit findings (483 observations)
Overview of the webinar
The thought of a regulatory audit generates anxiety and questions of compliance to many companies cGMP. This webinar will review how auditors are trained to conduct such audits and typical areas of focus. An effective auditing training program is a combination of knowing the regulations, what are the areas of focus based on risk assessments and adequate training in how to handle inspectors, what an audit team should be prepared for and what to avoid.
Regulatory requirements will be highlighted that apply to auditing, along with suggestions on how best to perform the audits, address the deficiencies found and expectations for corrective actions that may need to be implemented. Additionally, the webinar will provide recommended approaches to addressing regulatory audit findings.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- QA/QC
- Regulatory
- Manufacturing
- Engineering
- Validation
- Management
- Purchasing
- Vendors/Suppliers
Why should you attend?
This webinar will provide a general overview as to how to prepare for regulatory audits and what inspectors are trained to review to help assure compliance with the quality system requirements. In both cases, there are areas of focus that need to be reviewed and trained on in order to assure topics that represent the risk to the quality of the product or device are adequately covered. Selection of an audit team and training is also vital to help assure success when auditors arrive. The webinar will also include 5 suggestions as to how best to address audit observations.
Faculty - Mr.Kenneth Christie
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. His responsibilities specifically include quality system auditing, GMP training and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products. Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.