Who Should Attend:Anyone involved in sourcing raw materials, especially human tissues and cells to be used for biotherapeutic products. These include those working in Quality Assurance, Manufacturing, and Raw Material groups.
Click on the titles below to learn more about each session. Sign up anytime and receive links to recordings of any individual sessions or all four sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!
Not sure if this is the right course for you? Check out the FREE 45-minute course preview! Details below:
Content:
• Quick overview of biotherapeutic regulatory framework
• Defining starting materials for Advanced Therapeutic Medicinal Products (ATMP)
• USFDA and their HCT/P regulations
• Sections 351 vs. 361 and why the designation matters
• 21 CFR Part 1271 Subparts A-B
• FDA Recent Warning Letter Reviews
• EU Recommendations for Starting Raw Materials:
– Donated Cells
– Cells of Primary Origin
– Cells in a GMP Facility
– Allogenic Raw Material
• Review of EDQM Recommendations for Donor Facilities
Specifics of Good Tissue Practices: See the Regulatory Actions in Action!
Instructor: Dr. Laureen Little
Format: On-demand recording available now.
Content:
• Digging Deeper into Safety Testing of Human Allogeneic Cells in APIs
• Cell Safety Testing Recommendations
• Sterility Assurance of Aseptically Processed Products
• Subpart C Inspection Results
• Basis of GTP Warning Letters
• Overview of Form 483 Citations
• Discussion of RCDAD (relevant communicable disease agent or disease) and overview of recent issued guidances
• Comparison of 1271.45 to 1271.90 and recently issued warning letters and Form 483 Citations:
• Analysis of what went wrong and what should have happened
Ancillary Materials: Risk Classification and Testing Required Prior to Use in Your Manufacturing
Instructor: Dr. Laureen Little
Format: On-demand recording available now.
Content:
• Sourcing Ancillary Materials and Performing Risk Assessments
• Overview of Japanese Regulations and Recent Biological Product Approvals
COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.
Our website uses cookies and other similar technologies to improve our site and your online experience. By continuing to use our website you consent to cookies being used. See our Privacy Policy to find out more.
