This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing.
This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms. The testing procedures and the regulatory requirements with regard to cleanrooms qualification and certification will be discussed. This course will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing.
Areas Covered in the seminar:
- Design, qualification and operation of cleanrooms
- The testing procedures
- ISO 14644 series standards
- FDA’s 2004 guidance document for aseptic processing
Who Will Benefit:
Personnel working in sterile pharmaceutical manufacturing facilities and are responsible and involved in the activities, such as the cleanrooms qualification, maintenance, operation and monitoring at an ongoing basis.
- Validation staff
- Engineering Staff
- Microbiologist
- Production management and staff directly involved in cleanroom operation
- QA staff
- Team members of Quality Management System (QMS)
- Contractors
- Consultants
Instructor Profile
Nazia Dar , has over 25 years of experience in sterile and non sterile Pharmaceuticals and Cosmetic industries. She holds B.Sc. degree in Microbiology and Biochemistry and received ISO 9001:2000 Auditor Certificate from AQS. She has a proven records 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 and seminars to pharmaceutical professionals in Canada and overseas. Her areas of expertise are the Microbiological Environments, Cleanroom Controls and Sterilization Processes. Nazia is active member of PSG and DIA and is a member of IEST & PDA.
