The Sales & Marketing Effectiveness in Chemicals Forum will bring together industry leaders as well as experts responsible and deeply involved in sales and marketing strategies.
Interview with Eduard Cayón
Read the interview with Eduard Cayón, Director, International Association of Pharmaceutical companies – Asociación Forum Auditorías (AFA)
- What was the biggest change leading to the revision of the Validation Process approach?
Validation of an API or pharmaceutical product manufacturing process has historically been a kind of bureaucratic exercise, consisting of three batches meeting specification, making use of standard Batch Records and using a Validation Protocol and Report (often based on a standard template).
The new approach covers the whole Product Life Cycle activity ; ongoing activity starting at development scale-up and followed until the commercial scale. Process parameters and ranges are based on Design Of Experiments (DOE).
- In your opinion, what is the main difference between the classical and modern approach?
Through this new approach, the concept of Process Validation appears as an important value for the company not only to pass inspections but also to increase knowledge, reduce incidences and at the end, enhance efficiency – adjusting efforts to actual needs.
- How can quality by design and risk management assure continual improvement under ICH Q8 and Q11? Can you give us an example?
ICH Q8 and ICH Q11 provide guidelines on how to proceed to generate and manage knowledge about the process. Risk Management is a tool to be used throughout all stages of development to optimize efforts and to ensure process robustness and safety.
When the process is developed through the Quality by Design concept, the critical operations are identified through risk analysis, and in combination with experimentation, the best ranges for the parameters are characterized. The result is a robust process leading to a fluent scale-up and industrialization. On the other hand, routine exception management will be fluent as well.
- What is your biggest expectation for the upcoming conference?
The conference’s takeaway should be basically changing the way of thinking about the validation concept. New insights show that an optimized validation approach results in benefits from the business point of view as well.
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Turning Patient Feedback to Meaningful Resource for Care Delivery
Read the interview with Nasser Al Naimi, Deputy Chief Quality Officer at Hamad Medical Corporation, and Co-Director at Hamad Healthcare Quality Institute, and learn how to turn your data into strategic information to drive patient-family centered care.
Creating & Leading Patient Experience Excellence
Read the full interview with Dr. Ahmed Mohammad Abu-Abah, CEO at King Abdullah BinAbdulaziz University Hospital and gain insight into the creating & leading patient experience excellence.
Excelling in PV is not only about Technical Expertise
For a PV leader, to be successful can look like a daily Herculean work: meeting a crucial mandate to minimize harm to patients, while ensuring that a product is prescribed to the right population, and maintaining the highest level of compliance within a very complex set of worldwide regulations.