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Get your ticket now! Enjoy 30% OFF with code: NETPHARMAMICRO30
(*Promotion valid until March 16th)
Keynote Speakers:
SESSION I – March 25
09:00 | Reception & Accommodation
10:00 | Seminar opening
10:30 | CCS Block 1 – Ségolène Lebrun
From the emergence of the CCS concept to its entry into force with the latest version of Annex 1, requirements have evolved, and manufacturers have had to interpret, adapt, and above all propose solutions to respond to a new but constructive concept. What are the real expectations surrounding this concept, what do the other regulatory texts bring to the table, and what are the authorities’ concrete expectations with regard to this document that structures our quality management system?
COFFEE BREAK
12:30 | CCS Block 2 – Ségolène Lebrun
Scope of CCS, key technical pillars, link between CCS and risk management, identification of contamination sources, translation of risk into control measures, residual risks and monitoring, how to respond to the numerous requirements set out in writing through a document or system? How does CCS impact environmental monitoring and how can you integrate the response to these requirements into your documentation? Working and discussion session: faced with the specific requirements of environmentalmonitoring and CCS, how can you integrate the responses to these requirements into yourquality management system?
LUNCH
15:00 | EM Block 1 – Vanessa Figueroa
Rapid viable methods, biofluorescent particle counters, continuous monitoring, and integrated EM platforms are no longer futuristic, yet adoption throughout the industry remains cautious. This session looks at what is truly holding organizations back, from validation strategy and data interpretation to risk tolerance and operational disruption, and discusses how to introduce new technologies without creating compliance exposure.
COFFE BREAK
17:00 | EM Block 2 – Vanessa Figueroa
Environmental monitoring itself is not a control, it is evidence. This session explores how EM data can reveal whether contamination controls are actually working as intended. We will examine governance, accountability, trending design, alert and action management, and lifecycle review, with a focus on turning EM results into meaningful, risk-based decisions.
18:30 | End of Day 1
NETWORKING & COCKTAIL
SESSION II – March 26
09:30 | Reception and Accreditation
10:00 | CCS Block 3 – Ségolène Lebrun
How can a concept and regulatory requirements be made operational? The results and trends collected from environmental monitoring can be used for the CCS management review. Beyond simply generating data and interpreting it technically, how can CCS be made dynamicand concrete, rather than something to be endured? The implementation of a CCS life cycle seems to be the strong operational response to the existing risk of creating a dusty and unworkable document.
COFFEE BREAK
12:00 | EM Block 3 – Vanessa Figueroa
Microbiology should not sit in the background as a compliance function. When leveraged intentionally, it strengthens contamination prevention, supports operational resilience, and improves inspection readiness. This session connects microbiological capability to business performance and provides practical guidance that leaders can use to communicate its value at all leadership levels.
13:30 | OMBA – Anders Widow
Current status, pros and cons, use as IPC or QC, CAPEX/OPEX, succesful deployement strategies
LUNCH
15:30 | Customer Case
17:00 | Round Table Discussion
18:00 | End of Workshop
Get your ticket now! Enjoy 30% OFF with code: NETPHARMAMICRO30
(*Promotion valid until March 16th)
Keynote Speakers:
SESSION I – March 25
09:00 | Reception & Accommodation
10:00 | Seminar opening
10:30 | CCS Block 1 – Ségolène Lebrun
From the emergence of the CCS concept to its entry into force with the latest version of Annex 1, requirements have evolved, and manufacturers have had to interpret, adapt, and above all propose solutions to respond to a new but constructive concept. What are the real expectations surrounding this concept, what do the other regulatory texts bring to the table, and what are the authorities’ concrete expectations with regard to this document that structures our quality management system?
COFFEE BREAK
12:30 | CCS Block 2 – Ségolène Lebrun
Scope of CCS, key technical pillars, link between CCS and risk management, identification of contamination sources, translation of risk into control measures, residual risks and monitoring, how to respond to the numerous requirements set out in writing through a document or system? How does CCS impact environmental monitoring and how can you integrate the response to these requirements into your documentation? Working and discussion session: faced with the specific requirements of environmentalmonitoring and CCS, how can you integrate the responses to these requirements into yourquality management system?
LUNCH
15:00 | EM Block 1 – Vanessa Figueroa
Rapid viable methods, biofluorescent particle counters, continuous monitoring, and integrated EM platforms are no longer futuristic, yet adoption throughout the industry remains cautious. This session looks at what is truly holding organizations back, from validation strategy and data interpretation to risk tolerance and operational disruption, and discusses how to introduce new technologies without creating compliance exposure.
COFFE BREAK
17:00 | EM Block 2 – Vanessa Figueroa
Environmental monitoring itself is not a control, it is evidence. This session explores how EM data can reveal whether contamination controls are actually working as intended. We will examine governance, accountability, trending design, alert and action management, and lifecycle review, with a focus on turning EM results into meaningful, risk-based decisions.
18:30 | End of Day 1
NETWORKING & COCKTAIL
SESSION II – March 26
09:30 | Reception and Accreditation
10:00 | CCS Block 3 – Ségolène Lebrun
How can a concept and regulatory requirements be made operational? The results and trends collected from environmental monitoring can be used for the CCS management review. Beyond simply generating data and interpreting it technically, how can CCS be made dynamicand concrete, rather than something to be endured? The implementation of a CCS life cycle seems to be the strong operational response to the existing risk of creating a dusty and unworkable document.
COFFEE BREAK
12:00 | EM Block 3 – Vanessa Figueroa
Microbiology should not sit in the background as a compliance function. When leveraged intentionally, it strengthens contamination prevention, supports operational resilience, and improves inspection readiness. This session connects microbiological capability to business performance and provides practical guidance that leaders can use to communicate its value at all leadership levels.
13:30 | OMBA – Anders Widow
Current status, pros and cons, use as IPC or QC, CAPEX/OPEX, succesful deployement strategies
LUNCH
15:30 | Customer Case
17:00 | Round Table Discussion
18:00 | End of Workshop
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