Cleaning Validation for Cosmetics and Medical Device Manufacturers Training

Cleaning Validation

Training Overview

The national and international regulatory authorities (such as JFDA) expecting from manufacturers of pharmaceuticals, cosmetics, and medical devices , that they have written procedures for equipment and facilities proper and effective cleaning. The companies shall demonstrate that all their equipment used for different product manufacturing is clean prior to starting any product manufacturing mission. The manufacturers must demonstrate that the cleaning procedure routinely employed for a piece of equipment limits potential carryover (from the previously manufactured product, or cleaning agents) to an acceptable level. The limits established must be calculated based on sound scientific rationale.

This workshop will help  QA/QC officers, technical managers at cosmetics and medical devices companies, to get deep understanding of theoretical and practical aspects of cleaning validation objectives, regulatory requirements, acceptance criteria and required documentation of cleaning validation.

Program Outline

Day 1

  • The objective of cleaning validation
  • Advantages and limitations of cleaning validation
  • Elements of validation
  • Regulatory requirements
  • Cleaning procedures
  • The scientific basis for the accepted contamination limit 
  • The worst-case related to equipment 
  • The worst-case related to products
  • Sampling methods
  • Analytical methods
  • Storage period after cleaning
  • Documentation

Day 2

  • Practical Implementation and case studies

Who should attend

This workshop will be of particular interest to all those who need to learn about all the Cleaning validation, including: Pharmacists, Chemists, Biologists, Microbiologists, or Engineers who are working within QA/QC departments or regulatory departments of cosmetics and medical devices companies, that are required by regulatory authorities to demonstrate that they fully understand the cleaning validation requirements and able to implement them properly and effectively.

Certificate

A certificate of attendance for professional development will be provided to each participant who completes this workshop.

Facilitator Profile

Raed Salah, Co-Founder and Technical Director of Goodness Care

With over 25 years of experience in Pharmaceutical, cosmeceutical, and Medical Device Product Development, Manufacturing, R&D, QA, QC, Consultations, Training, GMP Compliance Implementation, and Regulatory Affairs.

Raed has strong experience in product registration within all Middle Eastern countries and has gone through the entire technical career life cycle. He has taken part in many training programs in Jordan and the Middle East as a technical trainer and facilitator. Full trainer profile here and here.

Interested in this training?

If you are interested in this training, please fill out the following form and we will get back to you at the soonest.