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ENVIRONMENTAL MONITORING COMPLIANCE LEARNING FROM FDA WARNING LETTERS

21

Feb

16:00

CET


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EVENT HEADER

Sponsored by

Particle Measuring Systems
 * Why attend?
 * Speakers
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WHY ATTEND?

According to FDA inspectional observations, pharmaceutical firms have received
more than one 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.



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KEY LEARNING OBJECTIVES

 * 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




AGENDA


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SPEAKERS

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Giulia Artalli
Global Product Line Manager Micro&Sterility

Giulia holds a degree in Biological Science and has extensive knowledge of
pharmaceutical microbiology. She has more than 20 years of experience in
supporting pharmaceutical companies to reach regulatory compliance, with a
specific focus on microbiological contamination control. She started her career
in research, before moving to corporate positions in the Life Science divisions
of industry leading companies, such as Becton Dickinson and Diversey. She
currently works as Product Line Manager for Microbiology and Sterility in
Particle Measuring Systems.



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Daniele Pandolfi
Global Product Line Manager Software, Systems and Services

Daniele Pandolfi is a Global Product Line Manager at Particle Measuring Systems
with over 17 years of experience in contamination control. He excels in product
management, collaborating with teams worldwide and staying up to date with
industry regulations and trends. Daniele is a seasoned public speaker at events
such as ISPE, PDA, and International Pharmaceutical Exhibitions. His expertise
has been featured in multiple publications including the American Pharmaceutical
Review and relevant GMP technology publication for pharmaceutical industry.



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