Learn Best Practices for Environmental Monitoring and How to Leverage Data for Actionable Insights.

Overview

GMP Academy, Environmental Monitoring Course is a 2-day course taught by industry experts. This course covers regulatory requirements and how to meet them for contamination control over viable and nonviable particles, discusses the future of regulatory requirements, and helps you understand steps and solutions to move into a paperless environment.

Course Topics

Introduction and Fundamentals of Cleanrooms
Fundamentals of Particle Counting
Introduction to traditional Microbiology Techniques
Applications: Cleanroom Standards ISO 14644, GMP
Applications: EU GMP Annex 1
Particle and Microbial Data Interpretation (How to Define Meaningful Alert and Action Limit)
Solutions: Particle and Microbial Portable Monitoring Best Practices
FMS Solutions
Alarm Rationale Solutions
Compressed Gasses Solutions

Get more information about each topic. COMPLETE COURSE SYNOPSIS HERE

Details

Dates

June 21,22

Price

Early Bird*: $1,040/person (Early Bird ends May 22)
Regular: $1,390/person

Location

Open Biopharma Research & Training Center
Carlsbad, CA

Registration

Hotel

Special pricing until May 24 at Cape Rey Carlsbad Beach, a Hilton Resort & Spa.

View Hotel Here

TRAINERS

Industry experts with global experience who will perform the training:

Dave Crance
Life Sciences and OEM Sales Manager, Particle Measuring Systems. Global PDA Aseptic Manufacturing speaker.

David Crance is the Life Sciences and OEM Sales Manager for PMS. With over 35 years of experience in contamination control and systems, he has been involved in the design and implementation of more than 700 environmental monitoring systems. He has been an instructor at the Parental Drug Association (PDA) for 18 years in Bethesda, Maryland.

Mark Hallworth
Pharmaceutical Manager, Particle Measuring Systems.

Mark Hallworth is the Pharmaceutical Manager for Particle Measuring Systems. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control.” He is part of ISO 14644 working group 15, and currently lectures for the PDA, ISPE, and other international societies.