cGMP Controlled Raw Materials - Designing Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification

Why Should You Attend:

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.

Manufacturers of FDA regulated products must have a clear understanding in preventing loss of expensively manufactured products because of the use of an adulterated raw material through 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 webinar will provide such guidance as to the process of ensuring that there all the steps are followed to avoid producing an adulterated product as defined by the 21 CFR 110.80 Processes and Controls. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. Guidance will be given as to the steps that every manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

Who will benefit:

This topic applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include:

• Quality Control Analysts and Management
• Senior Management
• Manufacturing Associates and Management
• Shipping, Receiving, Warehouse Personnel and Management
• Raw Material Receipt and Testing Personnel
• Quality Assurance Analyst and Management
• Quality Engineering Personnel and Management
• Supplier Quality and Auditors