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Cleaning Validation and Compliance Issues for
Pharma, Biotech and Medical Device Industries
Abstract:

This course is an intermediate level course designed for Q.C. Management, Analytical, Production, Process Engineering, Maintenance Supervisors
and other plant personnel engaged in the plant and production equipment.  It will help to scope out the effectiveness of cleaning procedures in
the various matrixes of drug products in the streams of processing and manufacturing.  It covers detailed treatment of residues, different
techniques of sampling, and the applicable microbiological and analytical procedures used to support Cleaning Validation and their verification.  A
major focus in this presentation is to develop a risk assessment strategy for scoping out Cleaning Validation inside Pharmaceutical, Biotech and
Device Companies.

The dynamics of interaction between various groups and functions in the Cleaning Validation Team is a key factor in the management of Cleaning
Validation.  The discussions will include effective training and documentation for a successful program.



Highlights of Topics:

  • FDA Perspective: Introduction and Historical Overview
  • Regulatory Compliance Issues
  • Case Histories
  • Non-Compliance
  • Cleaning Validation Historical Background
  • Cleaning Validation
  • Objective
  • Key Elements
  • How to Establish an Effective Cleaning Validation Program/
    Methods of Cleaning Validation
  • Equipment and Residues
  • Sampling Techniques
  • Analytical Issues
  • Microbiological Concerns and Contamination
  • Acceptance Criteria
  • Documentation and Protocol
  • Major Challenges in Cleaning Validation
  • Maintenance Program Monitoring Program