Course DatesTo be verified
Cost: €795 including course manual, lunch and refreshments.
Course Topics /Agenda:
1. Regulatory Background – FDA,IMB approach
2. Best Industry Approach to Cleaning Studies -Cleaning Strategies -Sampling Methods -Acceptance Criteria
3. Calculation of carryover limits
4. Cleaning Methods -Manual, -Clean in Place (CIP) -Steam in Place (SIP) -Clean out of Place (COP)
5. Methods for evaluating level of cleaning -Visual, -Based on Toxicity of substances -Swab Limits -Rinse Limits
6. Development of Bracketing procedures
7. Development of Worst case rating Procedure
8. Dirty Equipment Hold Time (DEHT)
9. Clean Equipment Hold Time (CEHT)
10. Identification of Hard to Clean Places
11. Layout of a Cleaning Validation Protocol
The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.
Safety Shoes – Not Required on this course