Process Analytical Technology: An FDA Guideline for Continuous and Batch Pharmaceutical Production

Product Id : FDA301
Instructor : Nissan Cohen
Jun 27, 2020 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Description

Process Analytical Technology (PAT) was released as an FDA guideline in 2004 to enhance production knowledge, process knowledge, and institute immediate feedback of a process during its operation.  This PAT guideline offered incentives to the industry to manage, control, and provide increased knowledge of the process to ensure compliance to Pharmacopeial mandates, URS, and SOPs.  This allowed for less validation sequencing, cost reduction in product loss, greater throughput, and almost the elimination of OOS conditions.

Why Should You Attend:

  • PAT can save hundreds of thousands of Dollars in validation costs when implemented. Do you know how to do this?
  • You will learn, the basic tenets of PAT. You will understand and learn the need for instrumentation, statistical process control, alert and action limits.
  • You will learn how to focus on the process and make definitive changes in the process long before the process is deemed out of control or exceeding a specification limit.
  • You will see and understand the use of pharmaceutical water systems using PAT principles.

Additionally, the FDA has stated that the use of PAT may provide for less stringent audits due to the amount of data gleaned from the process and process understanding.

You will learn how PAT will increase production throughput, uptime, reduce scrap, reduce rework, and ensure your process is under control at all times.

This 1.5 hour session will build a framework for your future production facilities.

Process Analytical Technology (PAT) was released by the FDA as art of the 21st century initiatives to help the biopharmaceutical with continuous and episodic processes. Real-time release had been elusive, until the PAT guidance, as all data and testing was laboratory based with little or no online instrumentation. The advent of online instrumentation with real-time or near real-time information transposed the knowledge of the process. Now any process could be determined to under control when all Critical Process Parameters (CPPS) and Critical Quality Attributes (CQAs).

Although the FDA has endorsed and offered this significant program to the biotechnology industry. The industry has been slow in its adoption. Only a hand few of companies have adopted PAT as the basic operation of their processes, validation, and continuing operations.

PAT when enacted can be an incredible worthy program economically. Increases in uptime, production, throughput, decreases in scrap, rejections, and bad production are all within the purview of PAT.

“You can’t have a bad product with a good process…and you can’t have a good product with a bad process” This innocuous quote best describes the tenets of PAT.

Areas Covered in the Webinar:

  • PAT philosophy
  • PAT applications as defined by the FDA
  • PAT usage instead of validation
  • The use of Instrumentation and feedback to have process understanding
  • Increase the knowledge of the process its operation using CPPs and CQAs
  • Use of online instrumentation for real-time release
  • Adoption of automation with integration to process using PAT
  • PAT initiatives
  • PAT and its integration with the data warehouse
  • PAT data acquisition, retrieval, and integration
  • Benefits of the implementation of PAT

Who Will Benefit:

Pharmaceutical personnel in:

Engineering, water systems, critical utilities, QA/QC, operations, production, production management, maintenance, engineering management, production engineering

From the Biopharmaceutical industry.

Speaker Profile:

A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.

Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3

Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.

Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone. Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.


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