2-day In-person Seminar on
Process Analytical Technology (PAT) is more than it seems
Course "Process Analytical Technology (PAT) is more than it seems" has been pre-approved by RAPS as eligible for up to 12
credits towards a participant's RAC recertification upon full
Register Now
completion.
Date & Time:
Instructor Profile:
May 10th and May 11th 2012
8 am to 5 pm PDT
Duration: 2 Days
Instructor: Steven S Kuwahara
Location: San Francisco, Marriott Marquis Downtown
Price : $1495.00
Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC
(for one participant)
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. ...more
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.
Areas Covered in the Session: Day 1, May 10, 2012
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Lecture 1: Introduction to PAT Your Necessity is our Priority l l l
What is PAT? What are the complications? Definitions for a better understanding
Lecture 2: The PAT Framework l
The questions that PAT must answer about the process
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The goals that should be met
Lecture 3: Process Understanding l
The principles and tools ¡ Tools and their used in combination ¡ Process analyzers ¡
Process controllers n Risk based approach n Real time release
Lecture 4: Implementation strategy l
Forming the PAT team
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Regulatory factors
Day 2, May 11, 2012 Lecture 5: Method Validation l
The role of method validation in PAT
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Elements of method validation that are critical for PAT Analytical methods for process validation
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Lecture 6: General Principles of process validation
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Definitions How process validation and PAT work together
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General considerations
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Lecture 7: Process validation: Stage 1: Process design l l l
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 l l l l
Process performance qualification Protocols and reports Concurrent release of product Documentation
Click here to register for this webinar Who Will Benefit: l l l l l l l l
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
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