Cleaning Validation Principles Training Course

27 June 2018

Kiev

Trainer:
Denys Ostrovnoy

 

Learning Objectives
  •  provide systematized information, teach or improve knowledge of the current GMP requirements for the cleaning process and cleaning validation approaches.

Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform cleaning validation and cleaning verification.

What you will receive by participating in the seminar:
  •  by taking part in the seminar, staff will receive the necessary knowledge and practical skills of organizing and conducting cleaning validation work.

 

Agenda

27.07.2018
09:30 – 11:00	Regulatory Aspects Cleaning validation Guidelines, & Expectations   •  US FDA   •  EMEA   •  PICs
11:15 – 13:00	Agents-Select and Justify the right Cleaning Agents for your Substrate/residue Documentation requirements for validation Toxicological evaluation Examples of calculations PDE and MACO Establishment of eligibility criteria Bracketing and choosing the worst case
13:00 – 14:00	Lunch break
14:00 –16:15	Recovery study Optimization of cleaning validation Development of protocols and reports on cleaning validation Methods of sampling Cleaning verification
16:30 -17:30	Test

 

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