Process Analytical Technology (PAT) is more than it Seems - US Seminar 2012 at San Francisco

Website http://www.globalcompliancepanel.com/control/s_product/~product_id=900008 | Edit Freely

Category seminar San Francisco, Process Analytical Technology,PAT,process validation, Steven S Kuwahara

Deadline: May 10, 2012 | Date: May 10, 2012-May 11, 2012

Venue/Country: San Francisco, Marriott Marquis Downtown 8 AM PDT, U.S.A

Updated: 2012-03-14 19:47:26 (GMT+9)

Call For Papers - CFP

Why should you attend: Any pharmaceutical worker who deals with the manufacture of products should attend this course in order to gain an understanding of the regulatory requirements that will allow the implementation of PAT. In particular, the middle level supervisors and managers who will need to initiate and execute the studies that will allow the implementation of PAT should attend this course. Companies interested in developing a PAT program should send their implementation teams to these classes so the workers will be able to understand the requirements and adopt an integrated approach to their implementation.

Course Modules:

Day 1, May 10, 2012

Lecture 1: Introduction to PAT

What is PAT?

What are the complications?

Definitions for a better understanding

Lecture 2: The PAT Framework

The questions that PAT must answer about the process

The goals that should be met

Lecture 3: Process Understanding

The principles and tools

Tools and their used in combination

Process analyzers

Process controllers

Risk based approach

Real time release

Lecture 4: Implementation strategy

Forming the PAT team

Regulatory factors

Day 2, May 11, 2012

Lecture 5: Method Validation

The role of method validation in PAT

Elements of method validation that are critical for PAT

Analytical methods for process validation

Lecture 6: General Principles of process validation

Definitions

How process validation and PAT work together

General considerations

Lecture 7: Process validation: Stage 1: Process design

Understanding what is being designed

Building control points into the process

Developing early specifications

Lecture 8: Stages 2 and 3: Process Initial and continued qualification

Process performance qualification

Protocols and reports

Concurrent release of product

Documentation

Who Will Benefit:

Directors

Managers

Supervisors and lead workers in Manufacturing

Process Development

Regulatory Affairs

Quality Assurance

Quality Control

Workers who will be participating in operations or the supervision of PAT teams or the work that will need to be done to implement PAT should participate

Contact Information:

Event Coordinator

Toll free: 800-425-9409

Fax: 302-288-6884

Email: supportglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Price: $1,495.00

GlobalCompliancePanel

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Wilmington, DE 19801, USA