Prescription and OTC GMP Training

Instructor: Loren Gelber
Product ID: 705718
Training Level: Intermediate
  • Duration: 90 Min
This Drug GMP webinar will review the pharmaceutical GMP regulations and discuss how to avoid deviation from them, what to do when deviations do occur and what happens when the regulations are not followed. It is crucial that all employees involved in pharmaceutical quality be familiar with these regulations and review them on a regular basis.
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Why Should You Attend:

Current Good Manufacturing Practice (GMP) regulations are the FDA regulations that describe the requirements for the manufacturing of all pharmaceutical products, both prescription (Rx) and over-the counter (OTC).

The course will cover all the sections of the FDA pharmaceutical GMP regulations. Preparing for FDA by self auditing, and how to correct errors found, will be discussed. How frequently to expect FDA inspections, how to handle FDA inspections and how to avoid FDA Enforcement Actions will also be covered. Examples from recent FDA inspection observations (483s) and Warning Letters will be discussed.

Areas Covered in the Webinar:

  • Current Good Manufacturing Practices - Examples will be given of how they work in practice.
  • Auditing - How to find and correct errors before the FDA finds them during an inspection.
  • Corrections - Investigations, memos of correction and changes made to work environment and practices to reduce the chance of future errors.
  • FDA inspections - what to do and not do during an inspection, how to react to FDA inspectional observations (form 483), and how to avoid or minimize a Warning Letter from FDA.
  • 483s - End of inspection meeting, responses and timelines
  • Warning Letters - Responses, timelines and re-inspections

Who Will Benefit:

  • Quality Control
  • Quality Assurance
  • Regulatory Affairs
  • Legal Individual Contributors
  • Supervisors
  • Managers and Directors
Instructor Profile:
Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

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 Medicinal Chemistry.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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