Learn Best Practices for Environmental Monitoring
GMP Academy, Environmental Monitoring Course is a 1.5 day course taught by industry experts. This course covers regulatory requirements and how to meet them for contamination control over viable and non viable particles, discusses the future of regulatory requirements, and helps you understand steps and solutions to move into a paperless environment.
Who Should Attend
Anyone involved in environmental monitoring, especially in a sterile manufacturing environment, including anyone involved in data management from contamination control . Typical job functions include Quality Assurance and Operations.
What you Will Learn/ Course Topics
- Fundamentals of Particle Counting
- GMP Requirements for Environmental Monitoring (including Annex 1 Update)
- Understanding and Applying ISO 14644-1, 2 (Cleanroom Certification, Monitoring, and Validation)
- Air, Compressed Gas, and Surface Sampling Techniques (Particle & Microbial)
- Contamination Control Strategy: How to create a Site Master CCS
- Particle and Microbial Data Interpretation (How to Define Meaningful Alert and Action Limit)
- Risk Management Methodology
- Data Integrity in Pharma (Standards, Guidelines and Best Practices)
- Paper to Paperless (Migrating Process, Trending and Efficiencies)
- Leveraging Data Management Software for Root Cause Analysis
- Pharmaceutical Liquids: USP <788> and <1788>
Get more information about each topic.
After the class, experience environmental monitoring in action. As a participant, you’ll have the opportunity to tour TBC and see their new state-of-the-art TBC® equipment in action with our MiniCapts®, Airnets®, and BioCapt® sensors; see how they are placed in the system to efficiently monitor and alert for contamination.
Strategic Senior GMP Scientist, Life Science Division
Mark has managed the design, installation and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field, he was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.
National Sales Manager, Particle Measuring Systems. Global PDA Aseptic Manufacturing speaker.
David has been in the Life Sciences business for over 30 years. He has lectured for pharmaceutical societies and organizations throughout the USA and Asia on environmental monitoring systems and their cGMP regulations. He has been an Instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland for
twelve years. David has been involved in the design and implementation of almost 500 environmental monitoring systems.
Global Pharma Advisory Specialist
Ugo has worked with pharmaceutical companies to support quality assurance and control. She is especially skilled in data-driven corrective and preventative actions for environmental monitoring and contamination-control strategies affecting medical devices and drug production. Ugo earned her Master’s in Biomedical Sciences; focusing on pharmacology, validation methodologies, and technologies to effectively streamline sterile manufacturing.
More questions: Contact Us