Current & Emerging Technologies in Sterile Manufacturing

About the Event

The ISPE Australasian Affiliate and PDA Australia Chapter are excited to be back collaborating on an in-person event in Melbourne; Current & Emerging Technologies in Sterile Manufacturing.

This year we bring you international experts representing our leading industry associations who will share their experience on how the pharmaceutical industry is evolving, adopting new technologies and increasing demand for personalised medicines and Advanced Therapeutic Medicinal Products (ATMPs).

We will look at the impact to and current feedback from industry on the revised Annex 1 requirements, as well as the use of exciting technologies such as Isolators, Robotic Systems, Augmented Reality (AR) and Rapid Microbial Methods (RMM).

This event provides the ideal forum to discuss the current and emerging regulatory requirements and technologies used in sterile manufacturing, and the challenges and opportunities these present.  

Key Speakers

Jörg Zimmermann is currently Vice President External Affairs for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. Jörg has been with Vetter for over 20 years where he has held various positions including overseeing drug development activities such as manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. During his time at Vetter's production site at Lake Constance he was responsible for process implementation, new product introduction, lyophilization process development and managed 5 production lines for aseptically pre-filled injection systems as the Director of Production. In his current role, he manages relationships with regulatory agencies, professional organisations and other partners in the pharmaceutical industry. Having studied pharmacy in Freiburg, Germany and Cardiff, Wales he is also a registered pharmacist. Jörg has volunteered as conference chair, track leader and speaker at conferences by ISPE, PDA, and Concept Heidelberg for over 20 years. In 2016, Jörg was elected to the International Board of Directors of ISPE. He is the immediate past Chair to the International Board of Directors and a member of the Executive Committee.

Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management. Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing, quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education. Ivy has been a part of the PDA community for over 20 years, during this time she has been instrumental in establishing the PDA India Chapter of which she was a board member from 2013 to 2019. She has volunteered her time to the Steering Committee for Awards in 2017, the Steering Committee for the PDA Letter Editorial Committee and is currently a member of the Task Force working on an ANSI standard for Quality Risk Management for Aseptic Processing. Ivy is also a member of the Science Advisory Board and has recently joined the Board of Directors for PDA Inc.

Take Back to Your Job

• Understanding of best practice for sterile manufacture and the expectations for compliance with global regulatory requirements.
• Feedback from industry and the expected impact from the Annex 1 revision.
• An overview of the application of robotics and barrier technologies in aseptic processing.
• Approaches on how to modernise sterile manufacturing through modernised microbiology and the streamlined microbiology laboratory with the use of automated testing solutions and rapid microbial methods.
• Risk based approaches to aseptic processing in clinical and commercial manufacture.

• Knowledge of the challenges and opportunities that ATMP and Cell & Gene therapy products present.
  

Who should Attend?

• Managers and staff who support or are directly involved in the manufacture of sterile medicinal products, medical devices or non-sterile products for which contamination control is important.
• Quality Assurance and Quality Control Personnel, Microbiologists, Sterility Assurance Specialists.
• Technical professionals and vendors who provide products and services to support sterile manufacturing operations.
• Research professionals interested in translation from research to clinical and commercial operations.