Evaluating Aseptic Processing and Manufacturing

Join the discussion as industry experts evaluate the importance of aseptic processing and manufacturing. The discussion will highlight the challenges impacting the bio/pharma industry, the intricacies of the regulatory landscape, and the necessity of addressing QC/QA early on, among other critical aspects.

Register Free: https://www.pharmtech.com/pt_w/evaluating-aseptic-processing

Event Overview:

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, and Feliza Mirasol, Science Editor, Pharmaceutical Technology Group, interview experts about aseptic processing and manufacturing. During the discussion, industry experts will evaluate the importance of aseptic processing and manufacturing, highlighting the challenges impacting industry, the intricacies of the regulatory landscape, the importance of understanding ‘nuances’ between products and processes, the necessity of addressing QC/QA early on, best practices to ensure aseptic sterility, and potential future trends.

Interviews featuring:

• Maik Jornitz, Founder and Principal Consultant of BioProcess Resources

This episode of Drug Digest is sponsored by:

• Kindeva
• Veltek

Key Learning Objectives:

• Understanding aseptic processing and manufacturing
• Overcoming challenges with aseptic manufacturing
• Anticipating and troubleshooting aseptic practices for multi-product facilities
• Keeping up-to-date on current aseptic regulatory requirements

Who Should Attend:

• Understanding aseptic processing and manufacturing
• Overcoming challenges with aseptic manufacturing
• Anticipating and troubleshooting aseptic practices for multi-product facilities
• Keeping up-to-date on current aseptic regulatory requirements

Speaker:

Maik W. Jornitz
Founder and Principal Consultant
BioProcess Resource

Maik W. Jornitz, Founder and Principal Consultant of BioProcess Resources, is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration and filter integrity testing. He has published multiple books, book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is board member and Senior Business and Strategy Advisor of DIANT Pharma. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.

In his previous roles, he was the CEO of G-CON for 10 years, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Register Free: https://www.pharmtech.com/pt_w/evaluating-aseptic-processing