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Quality is one of the main challenges for pharmaceutical manufacturers. How can a risk management approach change the existing quality system?

Risk management approaches are applied in product development up to continued process verification (e.g. ICH Q8-Q11). The quality system has shifted in recent years from a traditional model to a more integrated, dynamic and risk-based approach. In principle the evaluation of the risk to quality should be based on scientific knowledge, link to the protection of the patient, and extend over the product lifecycle.

In your opinion what are the main challenges to maintain compliance with evolving quality standards?

Main challenges relate to a clear understanding of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy that assure process performance and product quality.

How to mitigate risks and control variations in a continued process verification approach?

Quality systems in place should monitor process data, to detect any undesirable process variability and the necessary actions should be established. Data collected include process trend and quality of in-coming material, in-process material and finished product. The use of modern statistical software which enable literally instantaneous evaluation of data such as control charting and process capability indicators, is required. These data should be statistically trended and reviewed periodically to confirm the validated state.

What would you like to achieve by attending the Quality Risk Management & Process Validation in the Product Life Cycle conference?

I would like to gain insights from various companies with the implementation of continued process verification activities, approaching the management and evaluation of data and preventing potential pitfalls in its implementation.

Ahead of the Quality Risk Management & Process Validation in the Product Life Cycle, read here an interview with Mr Andreas Schreiner, Site Validation Head at Novartis Technical Operations Solids

About the conference:

This marcus evans conference will help delegates implementing a quality risk management approach into their existing quality systems, understanding how to assess and evaluate risks in their companies and with their Third party partners. They will also gain insights from various companies with the development of continuous process verification, approaching the management of data and preventing potential pitfalls in its implementation. Quality Risk Management & Process Validation in the Product Life Cycle Conference will take place from the 28th until the 30th of September 2016 in Berlin, Germany.

About the speaker:

Andreas Schreiner graduated from the University Erlangen, Germany in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London he joint Roche Vitamins as Head of Solids Processing. He moved in 2006 to Novartis and worked in various departments with increasing responsibilities from project leader to global technology platform leader. Since 2013 he works for the Manufacturing Science & Technology Department as Validation Head for Solid Dosage Forms. Andreas Schreiner is appointed board and steering committee member at various scientific organisations (EFCE European Federation of Chemical Engineers, ISPE DACH Containment, SGVC Swiss Society for Process Engineers, EMPA Swiss Material Science Technology).

Quality Risk Management & Process Validation in the Product Life Cycle

An interview with Novartis

Andreas Schreiner,

Site Validation Head at Novartis