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Cleaning Validation in Pharma
Pharma & Biotech

Cleaning Validation in Pharma

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Latest cleaning validation regulations and guidance

Latest cleaning validation regulations and guidance

Learning Objective

Sampling selection based on a risk assessment

Sampling selection based on a risk assessment

Learning Objective

Criteria for choosing the worst-case product

Criteria for choosing the worst-case product

Learning Objective

Cleaning validation protocol

Cleaning validation protocol

Learning Objective

Determination of residue limits

Determination of residue limits

Learning Objective

Revalidation for Cleaning validation

Revalidation for Cleaning validation



KEY TOPICS

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

TRAINER

Rob Walker

Rob Walker

Rob Walker GMP Consultancy Limited, Director

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market. Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain. A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA.

Learn More →