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?
7th Annual Pharmacovigilance & Risk Management Strategies
To improve your processes and day-to-day operations across all departments join us at the conference and protect patients worldwide.
12th Project & Portfolio Management in the Pharmaceutical Industry Congress
12th Project and Portfolio Management Congress in Europe presents a high-level meeting looking at the best ways forward in enhanced R&D productivity, forecasting and ultimately, optimizing balance throughout the lifecycle.
Interview: A holistic approach to the strategic planning process
Read the full interview with Ken Dobie, Founder & Principal of Skyemar Consulting, Former Director, Corporate Planning & Portfolio Management, Illumina and gain the insight into the aligning strategic priorities to portfolio management and associated resources.
Interview: East vs. West – Is there a regional approach to PPM in the US?
Read the full interview with Leigh Shultz, PhD, PMP, Associate Vice President, Project Management – Primary Care, Infectious Disease, Vaccines, Global Project & Alliance Management, Merck and gain insight into the regional approach to PPM across the US.
Interview: Project & Portfolio Management for Pharma & Biotech
Read the full interview with Eric Towler, Therapeutic Area Lead, BioPharma Project Management, Bristol-Myers Squibb and gain insight into the latest PPM trends.