Trainings By Informa Markets

Complete guide to creating an efficient cleaning process and a robust CV program

04 Dec - 05 Dec 2023   |   Dubai

Workshop Overview

Cleaning validation is a set of procedures to establish evidence that cleaning processes for manufacturing equipment prevent product contamination. In the current practice, the process of cleaning validation has become essential for the pharma, biopharma, & life sciences industries. 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 that might affect the safety of the patient in relation to the use of API & and finished drug products.

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

There are common but critical issues that are faced during the implementation of cleaning validation practices such as: a) Finding out worst case scenario b) Selecting suitable cleaning agents c) Identifying correct sampling locations d) Determining PDE value & e) Analytical methods & techniques to be used.

Program Focus

With 6 successful preceded editions, CPhI Conferences is pleased to announce the 7th edition of the Cleaning Validation Workshop scheduled on the 4th-5th of December 2023 in Dubai. This 16-hour workshop will be delivered over two consecutive days and will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based and first-principle approaches and risk management planning.”

This highly interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Benefits of Attending

  • 16+ hours of extensive learning on Cleaning Validation
  • Interactive case studies and group exercises
  • Well-known trainer
  • Dedicated Q&A sessions
  • Easy networking opportunities

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