Comparability Protocols are an essential component of product lifecycle management. Their successful use depends upon process and product knowledge, and the excellence of the firm’s analytical program. This 90-minute interactive seminar will go over this newly-updated FDA Guidance Document which expresses FDA’s current thinking on the salient topics relating to Comparability Protocols. This information-packed new draft guidance contains knowledge you must have, including, but not limited to:
- Overview of Comparability Protocols
- Typical uses of Comparability Protocols
- Items which must be included in every Comparability Protocol
- Submitting Comparability Protocols for multiple changes and products
- Modifications to an Approved Comparability Protocol
- FDA’s expectations for Life Cycle Management of Comparability Protocols
- And much more!