cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
Who should attend? This training applies to personnel/companies in the Pharmaceutical, Sterile manufacturing, Biotechnology and Medical Device Industries. The employees who will benefit most include:
• Quality Control Analyst and Management • Senior Management • Manufacturing Associates and Management • Quality Assurance Analyst and Management
Topics:
- Sterility approach, Control, assurance, and testing
- Introduction and history of Endotoxin testing
- USP Chapter 85 Bacterial Endotoxin Explained
Number of sessions: 2 sessions
SPEAKER
Mahmoud Hosnni Sayed Rashed
Microbiology and Bioassay Department Manager
+11 Years of experience in the field of quality control working for reputable multinational and local companies.
Shipping
Great stories are for everyone even when only written for just one person. If you try to write with a wide general audience in mind, your story will ring false and be bland. No one will be interested. Write for one person. If it’s genuine for the one, it’s genuine for the rest.
Review
Write a quote here from one of your customers. Quotes are a great way to build confidence in your products or services.