Cleaning Validation - Chemical & Microbiological Aspects
Instructor:
Nazia Dar
Product ID: 700790
- Duration: 60 Min
This one-hour seminar is designed to discuss the principles applied to the cleaning validation in a pharmaceutical industry. It will explain how to write a Cleaning Validation Master Plan and what are the critical elements have to be considered when designing a cleaning validation program at a Pharma plant.
Areas Covered in the seminar:
- Regulatory Aspects.
- Selection of worst case product or products.
- Levels of Cleaning, Cleaning Parameters, Type of Cleaning.
- MVP.
- Calculation of chemical residue limits based on.
- Therapeutic Dose.
- Toxicity Dose.
- Calculation for Equipment train.
- Microbiological aspects of cleaning and Calculation of limits Revalidation.
Who will benefit:
Those who are working in pharmaceutical manufacturing facilities and are responsible and involved in the activities, such as the equipment cleaning, maintenance and monitoring on an ongoing basis.
- Validation Staff
- Manufacturing Operators
- Microbiologist
- Production Management
- Staff directly involved in compounding and filling operation
- QA Staff
- Team Members of Quality Management System (QMS)
- Contractors
- Consultants
Nazia Dar, Assist QA Director- Microbiology, Dept. RA. He has over 25 years of experience in sterile and non sterile Pharmaceuticals and Cosmetic industries. She holds a B.Sc. degree in Microbiology and Biochemistry and received ISO 9001:2000 Auditor Certificate from AQS. She has a proven record of continuous improvement based on data trending and investigations. Her past technical experience includes several management positions in the areas of Production, QC, QA, Validation, and Process Development at multinational pharmaceutical organizations. Nazia is a presenter of several courses, seminars and webinars to pharmaceutical professionals in Canada and overseas. Her areas of expertise are sterilization processes, cleanroom qualification and environmental controls. Nazia is an active member of PSG and is a member of PDA , DIA and IEST.
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