CP-CLASH
The speakers:
Ruven:
Ruven Brandes has over 15 years of experience in the pharmaceutical industry. Known for his technical expertise and strong quality awareness, he is one of the top 100 IIoT influencers since 2020. As an engineer, the integration of technical aspects with GMP standards is particularly close to his heart. Through his diverse professional experience, Ruven has developed a comprehensive understanding of the multi-layered perspectives within the pharmaceutical industry. Active in expert committees such as ISPE and VDI, he is a sought-after speaker at congresses and an influential author in the industry.
Wolfgang:
Wolfgang Rudloff is CEO of Experts Institut Beratungs GmbH and has over 30 years of experience in the pharmaceutical industry. He specializes in GMP compliance, technical management and preparation for FDA inspections. His engineering background and leadership roles, particularly in cannabis consulting and GMP upgrade implementation, highlight his extensive expertise. Wolfgang is also a sought-after speaker and author.
In the opening episode of CP-Clash, Wolfgang and Ruven venture deep into the dense "paragraph forest" of regulatory requirements. They have an in-depth debate about the innovations introduced by Annex 1 and their potential impact on the pharmaceutical industry:
Can Annex 1 really help to streamline existing quality assurance processes? Wolfgang and Ruven investigate what specific changes are planned and how these could influence working methods.
The episode highlights how Annex 1 could make training on working in cleanrooms more efficient. Find out how these changes promote employee awareness and expertise.
The focus is particularly on excipient and primary packaging material suppliers. The discussion revolves around the extent to which they will now be held more accountable and what consequences this will have for the supply chain.
Join Wolfgang and Ruven as they explore the regulatory jungle and discover whether Annex 1 really helps to pave the way for clear and efficient processes.
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Wolfgang and Ruven continue their discussion about the technical aspects of Annex 1 in front of the crackling fire in the cozy fireplace room. In this episode of CP-CLASH, they shed light on how the requirements can be implemented in practice:
Which certificates are essential and which could be superfluous? The duo discuss whether and which certifications are really necessary to meet the requirements of Annex 1.
The right supplier management strategy is crucial, especially when working on critical equipment. Wolfgang and Ruven discuss how to work effectively with suppliers and what control mechanisms should be established.
Robust defense strategies are essential for critical assets. Our experts shed light on which strategies are most effective and how to ensure that critical control points are protected at all times.
Don't miss this insightful episode that highlights key technical aspects of Annex 1 and offers practical advice for implementation.
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