Environmental Monitoring in Partnership with Cherwell Laboratories

1 Day/s

CPD Hours: 7

Classroom, in-house

Run in partnership with Environmental Monitoring Process Validation Specialists, Cherwell Laboratories, the course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available, techniques employed to monitor pharmaceutical environments, data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods, trending and reporting of results is undertaken.

The course agenda includes Technical Representatives from Cherwell explaining Microbial Air Sampling options, implementation aspects and the classroom course also includes a tour of Cherwell's manufacturing facility.

This course is aimed at personnel in production and quality functions who wish to increase their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations. It will be of particular use to anyone performing environmental monitoring and those involved in collating and interpreting the results obtained.

This course covers the following topics:

  • Regulatory requirements and guidance
  • Overview of testing techniques
  • Demonstration of Cherwell equipment and media
  • Developing a program
  • Workshop on identifying risks
  • Calculating compliance limits
  • Interpreting results
  • Work Shop, identifying trends
  • Identification
    By the end of the course you will:

    • Understand the testing techniques regularly used in pharmaceutical production operations
    • Know how to interpret results and identify trends
    • Know what factors to consider when developing an environmental monitoring programme appropriate for your operations

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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Andy Martin

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

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