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Navigating pharmaceutical environmental monitoring in a changing industry

During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.

Pharmaceutical environmental monitoring ensures the safety and quality of drug products and medicines by taking a proactive approach to quality control. It is imperative that pharmaceutical professionals are up to date with key aspects that impact the sector such as regulation and legislation (eg, Annex 1) and new technologies, to deliver effective monitoring of cleanrooms, aseptic manufacturing suites and more.

Having the latest knowledge of essential elements such as a robust and holistic contamination control strategy (CCS), and regulatory considerations like good manufacturing practise (GMP), can help those working in the environmental monitoring to address challenges appropriately.

Furthermore, individuals in the sector should be equipped with the most up-to-date and adequate training, skills and knowledge so they can conduct activity in key areas such as water and air monitoring, sterile gown monitoring and validation, for instance, environmental monitoring performance qualification (EMPQ).

In this session, speakers share their expertise and insight on best practise and emerging trends to help pharmaceutical professionals navigate changes in the industry.

Key learning points:

  • Find out about the latest advancements and developments and major challenges impacting the pharmaceutical environmental monitoring sector in 2025.
  • Learn about how to enable regulatory compliance, ensure quality control, ways to handle risk management, and more. Attendees have an exclusive opportunity to ask questions on key topics from leaders in the sector.
  • Hear from industry experts on best practice in key areas such as regulation, manufacturing.

OUR SPEAKERS

MODERATOR:

Joel Russo – Pharmaceutical Microbiologist, Manufacturing & Lab Compliance Senior Consultant, Russo Consulting Group, LLC

Joel has 30 years of Microbiology experience including nearly 25 years of experience in pharmaceutical and other areas of GMP Manufacturing Quality, Compliance, and GLP Quality Laboratory Processes and Systems, specialised in Microbiological Control, Aseptic Processing, FDA Remediation, Quality Systems remediation in response to regulatory actions, 483’s Warning Letters, Consent Decrees, other regulatory reporting. Leading, mentoring and supporting investigation / CAPA committees and workgroups. Support of multiple PAI and FDA Product Approval efforts. Joel is currently the President of Russo Consulting Group which specialises in microbiological contamination control, laboratory and lab system architecture, lab compliance, manufacturing compliance, and validation efforts.

Fred Ayers, Senior Consultant – Microbiology, Valsource

Fred is Sterility Assurance and Contamination Control expert with over two decades of experience in providing strategic guidance for pharmaceutical manufacturing.  Currently, Fred leads and manages pharmaceutical and biopharmaceutical projects, specialising in Contamination Control Strategies, Microbiology, and Sterility Assurance.

He has been a Chapter Board Member of the Parenteral Drug Association (PDA) since 2014 and served as President from 2020 to 2021. Fred has also contributed as a Task Force Member for PDA Technical Report 90.  Additionally, Fred is an active committee member for numerous workshops and conferences and a standing member of the PDA Scientific Advisory Board.

Christine Caruso, Associate Director on the Global Microbiological Quality & Sterility Assurance team at Merck & Co., Inc.Christine Caruso, Associate Director on the Global Microbiological Quality & Sterility Assurance team at Merck & Co., Inc.

In her current role, Christine provides support and subject matter expertise to sterile, low bioburden and non-sterile sites across the Merck network, leads continuous improvement initiatives, and ensures network alignment with industry and regulatory expectations. She is the global quality management system owner for contamination prevention and control, and environmental and personnel monitoring. Christine has over 16 years of experience in the pharmaceutical industry including positions in commercialisation, manufacturing, technical operations, and quality.

Mirna Vazquez

Mirna Vazquez – Associate Product Manager Charles River Laboratories

Mirna has extensive laboratory experience with the MALDI-TOF system, she supervised environmental monitoring (EM) program for sterile compounding facilities prior to joining Charles River. Her experience in microbial identifications and EM allows her to emphasize the needs of our customers and develop solutions that drive long term success. Mirna received her BS in Biology from the University of Illinois Chicago and MBA from Strayer University.

FAQs

FAQs 

Is the panel discussion free? 

Yes – there is no charge to watch the panel discussion, either live or on-demand. 

How long will the panel discussion be? 

This panel discussion will last up to an hour. 

What do I need to watch this panel discussion? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.