COURSE ID 2764

Effective Handling of cGMP Raw Materials

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Charity Ogunsanya

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is an integral and essential process that ensures drug product quality, purity and potency. Drug product manufacturers must have a defined procedure that clearly shows how raw materials are received, stored, labeled, quarantined, tested, qualified, tracked, used, and discarded at the end of expiry.

This training will provide guidance to the process of ensuring that all the steps are followed to avoid producing an adulterated product as defined by the 21 CFR 110.80 Processes and Controls.

Upon completion of this course, you will be able to:

  • Describe the appropriate ways to design the processing of all cGMP Controlled raw materials.
  • List the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials.
  • Develop defined procedures for receiving, storing, labeling, quarantining, testing, qualifying, tracking, and discarding controlled raw materials.
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This online training is designed for personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries.

Employees and Management in the following areas will benefit greatly:

  • QA and QC Analysts
  • Manufacturing Associates
  • Shipping, Receiving, Warehouse
  • Raw Material Receipt and Testing
  • Quality Engineering Personnel
  • Supplier Quality and Auditors

Personnel who manage these individuals would additionally benefit from this training by gaining a better understanding of the issues faced in ensuring a GMP-compliant raw material program.

Course Instructor

Charity Ogunsanya

Owner/CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya’s Courses

Accreditation

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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