CERTIFICATE TRAINING

PHARMACEUTICAL CLEANING VALIDATION

Program Overview:

The cleaning of facilities and equipment is a critical activity to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. The residuals of active, detergent, toxins and excipients are increasingly deviations in inspections and audits. The cleaning and sanitation procedures need to be validated to demonstrate effective cleaning and sanitation program for facility, utility, equipment, health and hygienic practices.

Program Modules:

Module 1

  • Pharmaceutical Sanitation Programs
  • Generic Sanitation Program
  • Sanitation Validation/Verification
  • Cleaning validation Requirements

Module 2

  • Pre-operational Sanitation Assessment
  • Operational Sanitary Practices
  • Personnel Health and Hygiene
  • Premises Sanitation Requirements

Module 3

  • Sterile Validation
  • Types of Sterilization
  • Process controls
  • CIP/SIP

Module 4

  • Cleaning Verification and Cleaning Validation
  • Cleaning Master Validation Plan

Module 5

  • Preparing for Cleaning Validation
  • Process controls
  • Writing cleaning validation protocol
  • Writing cleaning validation report
  • Case study

Module 6

  • Effective sanitation program
  • Gap Analysis
  • Dirty hold time studies
  • Clean hold time studies
  • Deviations/CAPA/Change Control

Module 7

  • Writing cleaning validation protocol
  • Writing cleaning validation report
  • Case study

Enquire now

Location:


  • Individuals wanting to become a validation specialist/scientist/engineer
  • Validation Associates
  • Production Personnel
  • Technical team members
  • Management teams
  • Auditors

Testimonials

  • Robert Bess, B.Sc.

    Production Technician, Apotex Inc.

    NACPT helped me enormously and I shall be eternally grateful.

  • Dr.Taiwo Sonoiki

    Clinical Assistant

    For new immigrants like myself, the difficulty in obtaining Canadian references proves to be an important challenge.

  • Lorrein Muiruri, BSc., from UofT

    Clinical research Assistant, Inflamax Research Inc

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