Trainings By Informa Markets
Informa


Cleaning Validation Workshop - International

26 Oct - 27 Oct 2021   |   Virtual Course


Course Overview

Assurance Of Cleanliness In Product & Process Through Effective

Cleaning validation is a set of procedures to establish evidence that cleaning processes for manufacturing equipment prevents product contamination. In the current practice, the process of cleaning validation became essential for the pharma, biopharma, & life sciences industry. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations as well as prevent cross-contamination of chemical residues or microbes might affect the safety of the patient in relation to the use of API & finished drug products.

There are different guidelines issued by different authorities which provide guidance on the requirements for the cleaning process and suggestions on the strategy for Cleaning Validation activities. Global regulatory authorities like FDA & EMA ensures pharmaceutical companies should follow these defined guidelines while implementing cleaning validation practices. If those regulatory requirements are not fulfilled, companies receive warning letters during audit & inspections. It has become mandatory for all pharma & biopharma companies to make sure that they are following effective cleaning validation plans & procedure.

Program Focus

Understanding regulatory expectations & guidance on cleaning validation
Understand & implementation of ASTM E3106 and ASTM E3219
Risk assessment in cleaning and the Shirokizawa Matrix
Choosing best risk-based method - Total Organic Carbon Analysis
Qualification of visual inspection and the new ASTM E3263
Controlling risk through statistical process control
Reviewing risk for new product introduction using risk-based (HBEL) approach
Identification of correct sampling techniques to be used for cleaning validation

Benefits of Attending


Learn from industry experts and Guru of Cleaning Validation

Interactive case studies and group exercises

16+ hours of extensive learning from the guru of cleaning validation

Dedicated Q&A sessions

Exhibitor showcase and easy networking opportunities

Better understanding and implementation of regulatory guidance and expectations for cleaning validation.

Implement Risk Assessment for Cleaning Validation to prevent contamination and ensure patient safety.

Who Should Attend?


INDUSTRIES

  • Pharmaceuticals
  • API Manufacturers
  • Bio-Pharmaceuticals
  • Life sciences

DESIGNATIONS

  • Vice Presidents
  • Associate Vice Presidents
  • Directors
  • Associate Directors
  • Heads / Plant Heads
  • Deputy General Managers
  • General Managers
  • Senior Managers
  • Managers
  • Assistant Managers
  • Senior Executives

FUNCTIONAL AREAS

  • Quality Assurance
  • Quality Control
  • Production & Manufacturing
  • Validation
  • R&D
  • Regulatory




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26 Oct - 27 Oct 2021

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