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Particle Measuring Systems
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GMP Academy: Environmental Monitoring Course

GMP Academy full

 

 

 

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

Particle Counting training

Register Now

 

TRAINERS

Industry experts with global experience will be doing the training.

Lisa Lawson
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.

 

 

More questions: Contact Us

 

 

Details

Dates

TBD

Price

  • Early Bird*: $1,040/person (Early Bird ends TBD)
  • Regular: $1,390/person

Register Now

Location

  • Open Biopharma Research & Training Center 
  • Carlsbad, CA

Registration

Registration ends
TBD

Hotel

  • Special pricing until TBD at Cape Rey Carlsbad Beach, a Hilton Resort & Spa.

View Hotel Here 

Announcement: We are carefully watching the Coronavirus developments and have now postponed the dates until June.  We will cancel or delay further as needed. If you need a refund due to company travel restrictions, we will provide that.

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  • Molecular Monitors
  • Software / Data Management

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Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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