Prescription and OTC GMP Training
Instructor:
Loren Gelber
Product ID: 705718
Training Level: Intermediate
- Duration: 90 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
