PAT/QbD – Keeping an Eye on Your Quality

Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical,
  • July 23, 2013

PAT and QbD are a reality for the pharmaceutical and life science industries. Process data and data analysis tools significantly improve process understanding and control, ensuring quality and reducing the risk of non-compliant products.

  • For an existing batch production facility, the benefits can be seen in terms of reduced cost, lower inventory levels and a move towards just-in time production and supply
  • For a new production line, the benefits are the ability to quickly develop the manufacturing process, upscale to a robust process, perform validation more easily and even go towards continuous manufacturing

There are a number of tools that support PAT and QbD principles in development and manufacturing plants, such as process analyzers, process control tools and reporting tools. But to properly implement PAT and QbD, you need more than just supporting tools. You need software that intelligently interprets and interconnects data generated by these tools. Software that enables absolute data transparency by correlating data back to processes. Software that makes quality predictions, which allows process optimization. Siemens has developed this software solution, SIMATIC SIPAT ®.

The presentation will include proven examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing.

Pharmaceutical and life science companies may now gather in-depth process understanding, release products in real time and further develop processes based on “Quality by Design” (QbD) principles and manufacture “right-first-time.”

Keywords:

Speakers

Pamela Bruen, Life Sciences Industry Manager, USA, Siemens

Pamela Bruen has 15 years experience in batch automation including 11 years focusing on Pharmaceutical production.

Ms. Bruen earned her BS in Chemical Engineering from Lehigh University and subsequently achieved a Masters in Chemical Engineering from Villanova University. She began her career at Siemens Energy and Automation where she worked for five years as a batch product specialist. She then worked five years at Merck & Co in West Point, PA as an Automation Engineer supporting their Biologics Pilot Plant. Her responsibilities included automation from media buffer prep to bioreactor operation. After Merck she joined Honeywell where she provided Manufacturing Execution System (MES) technical demonstrations for the sales team. Her responsibilities continued through project implementation where she served as technical lead to ensure smooth transitions from sales through project implementation.

Most recently, Ms. Bruen returned to Siemens Industry as the Life Sciences Industry Manager. In her new role, she applies her knowledge of pharma to develop, implement and execute a growth plan to expand Siemens solutions throughout the pharma market. Ms. Bruen is involved in her local ISPE community where she serves as the membership chair for the Delaware Valley chapter and actively participates in the Oral Solid Dosage Community of Practice for International Society of Pharmaceutical Engineers (ISPE) International.

John Klaas, Corporate Account Manager, Siemens

John Klaas has 25 years experience in process automation systems including 15 years focusing on the Pharmaceutical industry.

Mr. Klaas earned his BS in Mechanical Engineering from New Jersey Institute of Technology. He began his career at Moore Products Co., where he worked for five years as a sales engineer in the Atlanta area. He then worked for seven years as an area manager for Moore Products Co. in Connecticut.

After the acquisition of Moore by Siemens, Mr. Klaas became a corporate account manager focusing on the Pharmaceutical industry.

Dr. Kjell Francois, Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT

Kjell Francois is Sr. SIPAT consultant and Business Area Manager at Siemens IS IT based in Ninove, near Brussels (Belgium).

Mr, Francois has a masters degree in Bio Engineering and a Ph.D. in Applied Biological Sciences from the University of Ghent. He wrote several publications in international peer reviewed journals and books in the field of predictive microbiology in foods, next to participations in several international symposia.

At Siemens, Mr. Francois worked for some years as project leader in LIMS (Laboratory Information Management Systems) projects before joining the SIPAT development and project team. He was Project leader of the first SIPAT project, being the PAREL project at the NVI. (Dutch Vaccine Institute) and lead engineer & project manager of PAT projects for Wyeth Medica Ireland, Gedeon Richter, Roche, TEVA and Grunenthal. He contributed in several additional PAT/QBD projects for customers like GSK, Ferring and Schering-Plough. Mr. Francois has been leading the Siemens PAT projects team since 2010.

Who Should Attend?

Professionals from pharmaceutical and life science companies with responsibilities and interests in the following areas:

  • QbD/PAT Development and Implementation
  • Production, Validation, Compliance
  • Process Engineering Quality Assurance (QA)
  • Quality Control (QC)
  • Regulatory Affairs
  • Research & Development
  • Business Development

Xtalks Partners

Siemens

The Pharmaceutical and life science industry faces the challenges of a dynamic market environment. Siemens offers the industry support in the form of its experience, expertise and a comprehensive performance spectrum. Classical process analytics and instrumentation, process control systems, automation technology, software solutions, energy management and a global servicing network provide the basis for improved product quality, higher productivity and drug supply chain security.

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