Webinar: Simplifying the Route to GMP | A Risk-Based Approach to Single-Use Implementation

The recent release of EU good manufacturing practice (GMP) Annex 1 provides drug manufacturers with clearer and more specific expectations for implementing single-use technologies into their process. This webinar focuses on how to form a regulatory strategy for quality risk assessments of single-use materials, and how drug manufacturers can leverage single-use supplier information to streamline the process and improve GMP compliance.   

Our experts provide a path forward for meeting Annex 1 contamination control strategy requirements: leveraging SUS product certification; assessing sterility, extractables, and leachables; and control of integrity and robustness. Ultimately, this webinar provides practical insights and strategies that ensure the production of drug therapeutics is both safe and efficient. 


What Will You Learn:

  1. Specific risk factors for implementing SU tools, as outlined in EP Annex 1 
  2. How to form a regulatory strategy based on a quality risk management approach 
  3. Requirements for SU system quality, sterility, E&L, integrity, and robustness


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Lorraine Borland

Manager of Process Technologies

Lorraine Borland is Manager of Process Technologies for Fluid Management Technologies where she is currently responsible for building regulatory knowledge and single-use process solutions across modalities and driving technical innovation through the regulatory landscape. With over 30 years cGMP experience, she is a subject matter expert for viral vector, plasmid DNA, mammalian cell-based products, cell therapy, and whole-cell bacterial vaccines manufacturing. Lorraine is active in industry advocacy with specific interests in standardization and simplifying the pathway for manufacturers’ route to market. 

Dr. Armin Hauk  

Principal Scientist 

Armin Hauk has held the role of Principal Scientist at Sartorius since 2016. After his PhD, he worked for more than 20 years in the chemical and pharmaceutical industry in Basel as head of laboratories, consultant and Qualified Person (QP). Armin is a lecturer and trainer in E&L at conferences and seminars and member of various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan). Armin is Chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).

Cecilia Anneren 

Head of Product Management, FMT

Cecilia Annerén is Head of Product Management, responsible for quality testing services of single-use systems used in critical applications, such as aseptic processing, final fill and advanced therapies. She holds a Ph.D. in medical cell biology and has subject matter expertise in bioprocessing, cell culture and cell therapy. Cecilia has more than 25 years of work experience from various leading research and marketing positions in both academia and the global biotech industry.

Dr. Samuel Dorey

Principal Scientist Materials & Irradiations

Dr Samuel Dorey joined Sartorius since 2008, where he is currently a Principal Scientist working on materials and irradiations within PD. Samuel is deeply involved in promoting and facilitating the application of alternative irradiation technologies. He is the co-chair of the BPSA X-ray committee, and one of the lead authors of both 2021 & 2023 BPSA technical guides on “X-Ray Sterilization of SUS”. He is also a member of the ASTM E61 and the Irradiation Panel, and one of the lead panelists with the Regulatory Bodies (FDA/EMA /PMDA) to discuss technology proposals on X-ray sterilization of SU systems since 2021.