Cleanroom Practices and General Chapter USP <797>
Duration : 90 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
The objective of USP <797> (Pharmaceutical Compounding-Sterile Preparations) is to provide a guideline of conditions necessary to maintain an environment appropriate for compounded sterile preparations (CSP’s). The most effective tool in environmental controls for any sterile laboratory work is the clean room environment. It is imperative that personnel are adequately skilled, educated, instructed, trained and monitored in the necessary aseptic techniques required to work within such an environment. In addition to personnel controls; facility maintenance, design, monitoring and risk assessments (product compositions) also play a critical role in determining the quality of a sterile environment needed for compliance. This training is intended as an overview of the recommendations set forth in General Chapter USP <797> for facilities and personnel who work with CSP’s; or for those entities and personnel that perform work in a general sterile or clean room environment.
Course Objectives:
• To identify which facilities and personnel that are impacted by USP <797>
• Become familiar with the different classifications of microbial contamination risks and examples
• Identify and become familiar with standard training practices employed to become compliant for USP <797> and general cleanroom procedures
• Implementing and maintaining a Quality environment (QA recommendations)
• Common areas for improvement of cleanroom environments
• Familiarization with validation activities necessary for qualifications
Course Outline:
• Who/What facilities are potentially impacted by USP <797>
• Classifications and examples of Microbial Contamination Risk Levels
• Personnel training and evaluation of aseptic skills
• Cleanroom Monitoring and behavior/types of clean rooms
• QA program for cleanroom and personnel monitoring and evaluations
• Areas for validation activities
• Common errors and microbial contamination found in the cleanroom/sterile environment and what to do
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Compounding Pharmacies and Pharmacists
• Nurses, Physicians and Medical Personnel who administer CSP’s
• Pharmaceutical and general contract laboratory companies/entities with cleanroom facilities
• Quality Assurance in the biotechnology/pharmaceutical technology industries
• General laboratory personnel and staff who do routine work in cleanroom or control testing environment
• Any pharmaceutical, biotechnology, general contracting and start up laboratory facilities, entities and personnel who work in controlled cleanroom environments
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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