GMP for Active Pharmaceutical Ingredients

Instructor: Paul Larocque
Product ID: 706621
Training Level: Basic to Intermediate
  • Duration: 90 Min
This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients. It is based on the requirements of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and its document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
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Customer Care

Fax: +1-650-362-2367

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Read Frequently Asked Questions

Why Should You Attend:

The field of GMP for API is quite specific with unique requirements especially for the definition of ‘starting materials’, that is, where in a long synthetic sequence do these GMP become applicable.

Areas Covered in the Webinar:

  • Regulations
  • Quality Management
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and in-process controls
  • Packaging and identification labelling of APIs and intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Rejection and re-use of materials
  • Complaints and Recalls
  • Contract Manufacturers (including laboratories)
  • Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
  • Specific guidance for APIs manufactured by cell culture/fermentation
  • APIs for use in clinical trials

Who Will Benefit:

Drug and biologic personnel working in production, R&D, regulatory affairs, QA, and QC.

Instructor Profile:
Paul Larocque

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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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.

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