The document provides information about a training on pharmaceutical quality systems organized by Quality Circle Forum of India (QCFI). QCFI is a non-profit organization that provides training to professionals at different levels in industries. The Ankleshwar chapter of QCFI has launched activities like 6-month evening coaching and campus training programs on pharmaceutical quality systems and regulatory guidelines for pharmaceutical industries. The training modules will cover topics like cGMP, documentation, sanitation, validations, quality risk management and ICH guidelines. The training will be participatory in nature followed by an evaluation test, and certificates will be distributed. It will be conducted by Dr. Milind Pathak, who has 29 years of experience in quality assurance, quality systems and

1. Introduction of Training on
Pharmaceutical Quality System
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Dr.Milind Pathak
Joint Secretary and Faculty,QCFI Ankleshwar

2. About QCFI
 A non – profit and non – political organization, engaged in the propagation of the
quality concepts in society as a whole.
 Quality Circle Forum of India (QCFI) organizes training programs for top and
senior managers, executives, supervisors , workmen and at various levels for
industries.
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3. Contribution to Pharmaceutical Industries
 QCFI, Ankleshwar chapter has launched following activities for pharmaceutical
industries.
 Six month evening coaching for professionals involved in pharmaceutical industries on
“Pharmaceutical Quality system and Regulatory Guidelines” at QCFI, Ankleshwar.
 Need based campus training program on the topics of Pharmaceutical Quality System.
 External training programs at selected venues for the participants from various
industries.
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4. Training Modules
1) Concept of cGMP
2) Maintaining good house keeping
3) Maintaining documents and records
4) Sanitation and Hygiene
5) Qualification and calibration concepts
6) Handling of out of specification results.
7) Cross-Contamination: Sources and Prevention
8) Corrective and Preventive Actions with statistical tools.
9) A new approach to Process Validation
10) Quality Risk Management (ICH Q9)
11) ICH Guidelines
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5. Methodology
 A participatory training session followed by evaluation test.
 Certificates from QCFI are distributed to participants.
 Answer sheets of evaluation are submitted to organization, if requested; to
comply regulatory documentation.
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6. Profile of Trainer
 Dr.Milind Pathak; Having 29 yrs.
Professional experience in various
industries, out of which 16 yrs at
senior management level in
quality department.
List of employer
Lupin laboratories Ltd.
Ficom Organics Ltd.
K.A.Malle Pharmaceuticals Ltd.
Chemox Chemicals Ltd.
J.B.Chemicals and Pharmaceuticals Ltd.
Zandu Chemicals Ltd.
ACTGEN Pharma Pvt. Ltd.
Riddhi Pharma Pvt. Ltd.
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7. Core Area of Trainer
Quality Assurance
Quality System
Regulatory Affairs
Regulatory Guidelines
Validations
R&D
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8. Prominent Organizations connected with Training
1) Lupin Laboratories Ltd.
2) Cadila Pharmaceuticals
3) Cadila Zydus
4) J.B.Chemicals and Pharmaceuticals Ltd.
5) Jubilant Life Sciences
6) SRF Limited
7) Sanofi – Aventis
8) Sun Pharmaceuticals
9) Raks India Ltd
10) Abbott
11) CTX Lifesciences
12) Apicore Pharmaceuticals
13) Ion- exchange Ltd.
14) Vihita Chemicals
15) Riddhi Pharma
16) Eskay Iodine
17) Galaxy Surfactants
18) Himani Organics Ltd.
19) United Phosphorous Ltd.
20) Avantor Materials
21) GRP LTD
22) RPG Life Science
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9. Thank You
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