How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
Duration : 90 Minutes
Dr. Loren Gelber,
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Me Read more
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.
Course Objectives:
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.
Course Outline:
• General Information about FDA Inspections
• Self Audit Process
• Planning for Inspections and Audits
• Practice or Mock Inspections
• Responding to inspectional observations
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
