I. Overview of Methods to Establish Residue Limits
II. Understand and Calculate Maximum Allowable Carryover (MAC) and 10ppm Limits
III. Learn How to Go from the Calculation to a Cleaning Validation Limit
IV. Setting Acceptance Criteria for Non-Product Specific Tests (e.g., Bioburden, LAL)
V. Interactive Exercise
Attendees determine rinse and swab cleaning validation limits based on performing MAC calculations.
The speakers really impressed me; not only were they impressive as experts, but also as teachers. Their energy and candor on the subjects presented was refreshing.
Being a reader of IVT journals for some time, I visited this conference for the first time. Many of the presentations were excellent and the knowledge sharing was fantastic!
Validation Expert, Sogeti
A good forum which allowed me to benchmark my approach to process validation to industry peers.
Validation Manager, Takeda Ireland Ltd