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

Overview: This course will present the regulations and guidelines that apply to process analytical technology. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as the work on a product proceeds, starting the early development process. The course will present the guidance document and the related regulations while describing the activities that will be required to meet the conditions under which a PAT program may be instituted.
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: support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA