Due to concerns related to the Coronavirus, we are cancelling the June EM Course. Next session dates are TBD.
Learn Best Practices for Environmental Monitoring and How to Leverage Data for Actionable Insights
Overview
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.
After the class, experience environmental monitoring in action. As a participant, you’ll have the opportunity to tour Argonaut Manufacturing Services and see their new state-of-the-art Bausch+Ströbel VarioSys® 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.
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)
- Moving from Settle Plates to Continuous Active Air Sampling
- 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. COMPLETE COURSE SYNOPSIS
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TRAINERS
Industry experts with global experience will be doing the training.
Lisa Lawson
Global Adviser, Particle Measuring Systems.
Lisa G. Lawson has over 25 years’ experience in supporting large and small pharmaceutical companies in contamination control, including cleaning and disinfection strategies, aseptic manufacturing and use of risk-based approaches to microbiological quality challenges. She spent 16 years working for Amgen in microbial and mammalian cell culture manufacturing support and helped gain commercial FDA and international regulatory approval of the EPO/NESP manufacturing facility in Longmont, CO.
Dave Crance
National Sales Manager, Particle Measuring Systems. Global PDA Aseptic Manufacturing speaker.
David Crance is the Life Sciences Sales Manager for Particle Measuring Systems and 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. In his role as Life Sciences Sales Manager, he works with leading engineering firms
and manufacturers in the designing of Environmental monitoring systems.
Maurizio Della Pietra
Global Data Management Specialist and Process Advisor, Particle Measuring Systems.
Maurizio Della Pietra is the Global Data Management Specialist and Process Adviser for Particle Measuring Systems. In this role, he collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. His expertise includes QA processes, validation of equipment, utilities, facilities, computer systems, aseptic production processes, and statistical analysis of aseptic production processes. He has earned a Master’s Degree in Physics.
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