Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

Duration: 90 Minutes
In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine. In some countries, OTC manufacturers are treated the same way as other drug manufacturers - their products are after all medicines and are inspected to the same standards and at the same frequencies. In the U.S., OTC manufacturers must meet 21 CFR 210/211 and current good manufacturing practices (cGMPs).
Over-the-Counter GMPs
Instructor: Loren Gelber
Product ID: 506801
Objectives of the Presentation
  • Learn to reduce the risk of FDA regulatory action
  • Learn to reduce the number and frequency of audits
  • Learn to ensure brand protection and integrity
  • How to avoid potential recalls and reduce risk to customers
  • How to improve quality of products sold to consumers
  • How to improve culture of quality in the organization and demonstrate a commitment to quality
  • Meet current expectations to stay ahead of your competition
Why Should you Attend
Prescription and OTC cGMPs is a system for ensuring that products are consistently produced, packaged, tested and controlled according to current, established quality standards. The GMPs are designed to minimize the risks involved in any pharmaceutical operation. The GMPs cover all aspects of production from starting materials, facilities and equipment to training and personnel hygiene.

This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products.

Areas Covered
  • Manufacturing, Packaging and Labeling procedures
  • Over-the-Counter (OTC) Monographs vs. NDA/ANDA cGMPs
  • Quality Systems
  • Production and process controls
  • Personnel qualifications and responsibilities
  • Cleaning procedures
  • Building and facility maintenance
  • Packaging and labeling procedures
  • Equipment validation
  • Holding and distribution
  • Laboratory operations
  • Recordkeeping
  • Product traceability
  • Identity testing
Who will Benefit
This course will provide valuable information to the following personnel in the pharmaceutical industry:
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Compliance
  • Manufacturing
  • Scientists
  • R&D
  • Engineers
  • Product Development
  • Risk Management
$375
Recorded Session for one participant
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Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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.
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