Training Overview
The national and international regulatory authorities (such as JFDA) expect manufacturers of pharmaceuticals, cosmetics, and medical devices they have written procedures for equipment and facilities for proper and effective cleaning. The companies shall show that all their equipment used for different product manufacturing is clean before starting any product manufacturing mission. The manufacturers must show that the cleaning procedure routinely used for equipment limits potential carryover (from the previously manufactured product or cleaning agents) to an acceptable level. We need to calculate the limits established based on sound scientific rationale.
This workshop helps QA/QC officers, and technical managers at cosmetics and medical devices companies, to get a 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 aim 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 particularly interest 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 the regulatory authorities require showing that they fully understand the cleaning validation requirements and able to implement them correctly and effectively.
Certificate
We will provide a certificate of attendance for professional development 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 substantial experience in product registration within all Middle Eastern countries and has gone through the entire technical career life cycle. He has participated in many training programs in Jordan and the Middle East as a technical trainer and facilitator.
