Vendor Management for Pharmaceuticals, Biologicals, and Medical Devices
Instructor:
Paul Larocque
Product ID: 706689
Training Level: Basic
- Duration: 90 Min
Why Should You Attend:
FDA requires pharmaceutical, biological, and medical devices manufacturers to establish and maintain control over their suppliers to ensure the purchased goods or services meet Good Manufacturing Practices.
In this webinar, you will learn FDA’s expectations for the implementation and on-going operation of an effective vendor oversight program.
Areas Covered in the Webinar:
- Pharmaceuticals
- Biologicals
- Medical devices
- Finished Product (contract manufacturing)
- Chemicals (including Active Pharmaceutical Ingredients and excipients)
- Packaging Materials (primary, secondary, & tertiary)
- Labelling (printed) Materials
- Services (including contract laboratories and contract sterilizers)
Frequently Asked Questions:
- On the DMF, what constitutes a need to update this DMF? Is it a change in Supplier or only Mfg. and location?
- I work for a contract mfg. site. we get material from distributors and mfg. are we required to audit the mfg. even though we are purchasing directly from a distributor?
Who Will Benefit:
Pharmaceutical, biological, and medical device company personnel working in production, R&D, regulatory affairs, QA, and QC.
Instructor Profile:
Paul Larocque
President, Acerna Inc
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.
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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).
