Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations.
It will explain how to establish cleaning procedures as well implement and enforce them in order to maintain the required level of cleanliness. Cleanroom procedures and operators behavior have a significant impact on its overall cleanliness and subsequently impact the product quality. It needs a deliberate efforts and knowledge to establish a good training and qualification program for the cleanroom operators. Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations.
Areas Covered in the seminar:
- Points to consider during the Risk assessment of various factors that may influence the cleanrooms cleanliness level
- Cleanroom Cleaning program & Schedules
- Cleanroom Operators Training and Qualification
- Monitoring Cleaning Effectiveness and Testing
Who Will Benefit:
Those who are working in sterile pharmaceutical manufacturing facilities and are responsible and involved in the activities, such as the cleanrooms maintenance, operation and monitoring at an ongoing basis.
- Operations
- Quality Control
- Quality Assurance
- Cleanroom Operators
- Facilities Personnel
- Regulatory & Manufacturing Supervisors
- 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 Certificates 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.
