Clean room Design, Certification & Validation
Overview:
This live webinar provides a thorough examination of designing and starting-up cleanrooms. We will explore the design considerations for cleanrooms. The webinar also discusses certification and validation strategies based upon tried and true industry practices, guidelines, and standards.
The key benefits of this course are:
- In-depth understanding of cleanroom design.
- Achieve satisfactory inspections more easily.
- Higher assurance of new medical product approvals.
- Minimize non-conformances.
- Reduce rates of batch rework and rejections.
- Reduce product contamination issues.
- Avoid product recalls.
- Understand industry standards in cleanroom certification and validation.
Why should you attend: Cleanrooms used in manufacturing human medical products can have a profound impact on the quality of our products and operation of our plants. Cleanroom issues can result in manufacturing delays, non-conformances, recalls, and regulatory action. Therefore it is important to properly design, certify, and validate cleanrooms and ensure best practices are followed.
Areas Covered in the Session:
- Identify components and equipment and what they do.
- Compare cleanroom classes.
- Identify certification requirements.
- Identify validation strategies, requirements, and documentation.
Who Will Benefit:
- Q Auditors and Personnel
- Manufacturing Operators
- Maintenance Cleaning Personnel
- Operations managers
- Microbiologists
- Validation Personnel
- Training departments
- Consultants