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How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
- General Information about FDA Inspections
- Self Audit Process
- Planning for Inspections and Audits
- Practice or Mock Inspections
- Responding to inspectional observations
Overview of the webinar
This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how to behave during one will be reviewed. The usefulness of mock inspections and other practice routines will be considered. How to respond to FDA inspectional observations (FDA form 483) and customer observations will also be discussed. How to avoid FDA Warning Letters, and when it is possible to do so, will be reviewed.
Who should attend?
- Internal / External Auditors
- Regulatory Management
- Quality Assurance Professionals
- Consultants
- Sales/Marketing Management
- Senior and mid-level Management
- QA/QC
- Compliance
- Regulatory Affairs
- Operations and Manufacturing
Why should you attend?
All pharmaceutical firms, whether Over-the-Counter or Prescription, are subject to FDA inspections as soon as they submit a drug listing, an application for a new or generic drug, or introduce a drug into interstate commerce. Customers, such as chain drug stores, are also likely to audit a new firm before buying anything from them and periodically thereafter. If a firm has a process in place for self-auditing, inspection planning, and practice, they are more likely to have a successful FDA inspection or customer audit.
Faculty - Dr.Loren Gelber
Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.