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A New Approach to Process Validation – 2Day Training Programme
April 29, 2016 - April 30, 2016
Introduction:
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A revised guidance on A New Approach to Process Validation published in Jan. 2011, provides recommendations that reflect some of goals of FDA’s initiatives entitled “Pharmaceuticals GMP for the 21st Century, A Risk-Based Approach”, particularly with regard to the use of.
* Technological advances in Pharmaceutical manufacturing.
* Implementation of a
– Risk Management
– Quality System tools and management.
A New approach to Process Validation has been linked with a “Product life cycle concept” which includes stages,
– Process Design
– Process Performance Qualification
– Continued Process/Quality Verification.
Objective:
An objective of this training program is to explain FDA’s expectation regarding new approach of process validation.
Certificate:
Certificate will be awarded to the participants after successful compliance of the test at the end of the training programme.
Methodology:
A New Approach to Process Validation (Inlight of ICHQ8-Q11) guidance will be explained in detail with suitable examples and rationale. It will be a participatory session and followed by an evaluation on second day.
Faculty:
Dr. Milind Pathak – (M) 09377434079
* Having 29 years of experience in reputed APIs manufacturing industries at various capacities in QA and
Regulatory Department.
Date, Time & Venue: 29th – 30th, April – 2016 : 9.00 A.M. to 5.00 P.M. Hotel Dev Corporate, Opp. Bawarchi Restaurant, Off.C.G.Road, Nr.Girish Coldrink Cross Road, Navarangpura, Ahmedabad.
Fees:
Rs. 4000/- per participant + Service Tax @ 14.00 + 0.5 % SBC = Rs. 4580/- Course Fee includes training material, Tea / Snacks and working Lunch.
Discount:
10% Discount for QCFI-Life Members. 5% Discount for 3 or more participants from QCFI – Institutional Member organizations.
Enrollment:
Please e-mail the list of names of participants along with local cheque/Demand Draft in favour of “Quality Circle Forum of India” at Mr. Milan Sheth, QCFI, Proposed Ahmedabad sub Chapter: Mo. 098794 77357, E-mail : milan_sheth1@yahoo.com
Dr.Milind Pathak, Joint Secretary & Faculty, QCFI, Ankleshwar Chapter: Mo.9377434079, E-mail : niketan35@yahoo.co.in
QCFI, Ankleshwar Chapter: Ph.02646 – 247461, E-mail : qcfi.ank@gmail.com
Last Date For Registration : 18th April – 2016
