Cleaning Validation in Pharma
Cleaning Validation in Pharma

Course Description

This 3-day training covers a systematic evaluation and understanding of Cleaning validation regulations, risk reduction, and GMP requirements, focusing on the development of Cleaning validation protocol, Method Validation, Sampling techniques, and Recovery Studies.
  • Cleaning validation regulations and guidance
  • GMP requirements for a Cleaning validation protocol
  • Setting Limits to Methods of Calculating Acceptance Criteria
  • Method Validation, Sampling techniques, and Recovery Studies
  • Risk assessment and implementation of available PDEs
  • Case studies for cleaning validation limits and MACO data
  • Latest cleaning validation regulations and guidance
  • Sampling selection based on a risk assessment
  • Criteria for choosing the worst-case product
  • Cleaning validation protocol
  • Determination of residue limits
  • Revalidation for Cleaning validation

Cleaning Validation in Pharma

11 - 13 March 2024, Live Online Training
€1.850,00
Rob Walker

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry.

START TIMES

9:00 AM Vienna time

8:00 AM London time

4:00 AM New York time

1:00 AM Los Angeles time

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Course Description

This 3-day training covers a systematic evaluation and understanding of Cleaning validation regulations, risk reduction, and GMP requirements, focusing on the development of Cleaning validation protocol, Method Validation, Sampling techniques, and Recovery Studies.
  • Cleaning validation regulations and guidance
  • GMP requirements for a Cleaning validation protocol
  • Setting Limits to Methods of Calculating Acceptance Criteria
  • Method Validation, Sampling techniques, and Recovery Studies
  • Risk assessment and implementation of available PDEs
  • Case studies for cleaning validation limits and MACO data
  • Latest cleaning validation regulations and guidance
  • Sampling selection based on a risk assessment
  • Criteria for choosing the worst-case product
  • Cleaning validation protocol
  • Determination of residue limits
  • Revalidation for Cleaning validation

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Cleaning Validation in Pharma

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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