On Demand | Duration: 60 mins

Environmental Monitoring Compliance Learning from FDA Letters on demand webinar

According to FDA inspectional observations, pharmaceutical firms have received more than a thousand warning letters (483) due to deficiencies in their environmental monitoring systems. Our experts, Giulia Artalli and Daniele Pandolfi, will discuss these findings and explain how they can be avoided in accordance with the latest EU EudraLex vol. 4 – GMP Annex 1 and ISO 14644.

This webinar will provide insights into how to enhance your Contamination Control Strategy (CCS), improve data management practices, develop continuous microbial active monitoring protocols, and effectively handle tubing length requirements (14644-21) using appropriate tools.

 

What you’ll learn:

  • Data Quality and CFR21 Part 11 best practices
  • Continuous microbial monitoring strategies according to new Annex 1
  • How to leverage system automation to ensure compliance
  • Mastering the particle sampling tubing length challenge
  • Data trending for viable and non-viable particles as a key element for your decision process

Who should attend:

  • Quality Assurance
  • Quality Control
  • Validation Experts
  • Production Teams
  • IT
  • Environmental Monitoring Teams
  • Compliance Specialists
Webinar Presented By:
Giulia Artalli
Global Product Line Manager Micro&Sterility

Doctor in biological sciences with experience in pharmaceutical microbiology, currently Global Product Line Manager at Particle Measuring Systems. She started her career in research, before moving to work for companies’ leader of the market such as Becton Dickinson and Diversey with a specific focus on Life Science market.
Giulia has extensive professional experience over 20+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. In her current role, she is focused on microbial EM supporting customers in the correct application in compliance with regulatory specifications.

Daniele Pandolfi
Global Product Line Manager, Software, Systems and Services Particle Measuring Systems

With over 17 years of experience in contamination control, Daniele Pandolfi excels in product management, collaborating with teams worldwide and staying up to date with industry regulations and trends.

He is a seasoned public speaker at events such as ISPE, PDA, and iInternational pharmaceutical exhibitions. His expertise has been featured in multiple publications including the American Pharmaceutical Review and relevant GMP technology publication for pharmaceutical industry.

With a strategic and innovative approach, Daniele is passionate about sharing knowledge on regulatory requirements, technological trends, and contamination control experiences to help pharma users achieving their compliance goal.