Raw Materials in Pharma/Biotech Production

In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.

Why Should You Attend:

This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing. By the end of this program, you will understand the requirements for raw material selection, receipt, testing, storage, and use. Guidance and skills for practical implementation of regulatory requirements will be presented.

The program will address approaches to selecting primary and secondary suppliers of raw materials, developing an incoming receipt and testing process, adequate and appropriate storage, and other considerations for the raw materials used in drug product processing. The information obtained will also enable completion of the raw material information in Module 3 of a CTD application.

Areas Covered in the Webinar:

• Selecting raw material suppliers
• Receipt, Testing and Storage of starting materials
• Control strategy
• Submission of information
• Life cycle management

Who Will Benefit:

The following professionals from Pharmaceutical and Biotech Industries:

Quality Assurance, Quality Control (Chem and Micro), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Utility Operations, Regulatory Affairs.