Overview
EU GMP Annex I revision encourages deterministic, quantitative, and reliable non-destructive technologies for leak detection. The document introduces the Quality Risk Management (QRM) methodology to comply with high-quality standards and harmonise with ICH9 and U.S. Pharmacopeia (USP) 1207 guidance.
The regulatory document requires the operators to address the process in a more statistically scientific way, introducing the concept of Contamination Control Strategy. This means addressing primary container integrity with a more global approach and shifting from probabilistic sterile testing to deterministic closure testing.
In this webinar, we will illustrate the impact this approach has on parenteral product inspection and container closure integrity. Leveraging on Stevanato Group's wide expertise, we will guide the audience through this journey to enhance patients' safety and package integrity during the entire life cycle.
Learning Objectives:
- Annex I Quality Risk Management Implication in visual inspection and CCI
- Visual Inspection and Annex I
- Contamination Control Strategy and Quality Risk Management
- Closure Container Integrity (CCI) and Annex I
Speakers:
Dr. Andrea Sardella
Pharma Inspection Product Development Manager - Stevanato Group
Degree in Physics at Padua University in 1989, master in Nuclear Engineering in the 1990. As researcher at the National Research Council (C.N.R.) he developed several scientific instruments for Magnetically Controlled Fusion Research setting up international collaboration with UWA Madison (USA) and Garchin IPP (De). After 10 years of activity in research, he moved to the industrial sector in the pharmaceutical field and developed innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group as R&D Manager to develop new automation and inspection products.
Reece Armstrong (Host)
Editor
After achieving a Master’s in Journalism from Newcastle University, Reece covered the digital health industry for a number of years before becoming Editor of European Pharmaceutical Manufacturer magazine. In his time covering the life sciences industry, Reece has interviewed experts within med-tech and pharma, whilst also reporting on breaking news such as medical device scandals, employee welfare in pharma and digital barriers facing the NHS.
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