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.
Learning Objectives:
- General Information about FDA Inspections
- Self Audit Process
- Planning for Inspections and Audits
- Practice or Mock Inspections
- Responding to inspectional observations
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.
Instructor Profile:
Dr. Loren Gelber is
currently an independent consultant, based
in Charlotte, NC.She previously was
employed by Akesis, Bestsweet, RRI, Andrx,
Royce, Universal Research, Danbury
Pharmacal, Barr and the US FDA. She has
been in Regulatory Compliance, Regulatory
Affairs, Clinical Research and Quality
Control Laboratories.
Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.
Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.