When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later.
This webinar is intended to discuss FDA regulations and the requirements for an effective cleanroom and facility validation as part of current good manufacturing practices (CGMP) for sterile drug and biological products.
Understand what firms should know about the statutory and regulatory requirements so that the industry can implement good manufacturing practices to ensure an effective cleanroom design and validation. This session will greatly help you understand and establish an effective environmental monitoring program in view of CGMP (USP, ISO and FDA recommendations).
Areas Covered in the Session :
- Applicable Laws and Regulations
- Key Definitions
- CGMP Practice Requirements for the Pharmaceutical Industry
- Regulations Governing Buildings and Facilities
- International Standards and Guidance Documents: ISO, USP, and FDA
- Comparative Overview of Air and Cleanroom Classification: FDA, ISO and EU EMA
- What to Consider When Designing a Cleanroom
- Cleanroom Validation: Principles and Testing
- Determining What Tests to Perform During a Cleanroom Validation
- Key Requirements for Personnel Training, Qualification and Monitoring
- Important Laboratory Controls
- Implementing an Effective Monitoring Program
- FDA Enforcement Actions
- PASS-IT Suggestions
Who Will Benefit:
- Professionals from the healthcare industry: drugs, biologics, medical devices/IVDs, Combination products, etc.
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Laboratory Personnel
- R&D Professionals
- Other professionals interested in this topic