TWO DAYS TRAINING PROGRAM – QCFI Ankleshwar Chapter & Surat Sub Chapter

TWO DAYS TRAINING PROGRAM
ON
GOOD MANUFACTURING PRACTICES WITH
GLOBAL APPROACH TO RISK MANAGEMENT &
CONTINUAL IMPROVEMENT

INTRODUCTION :
Good Manufacturing Practices intended to provide guidance regarding cGMP for manufacturing of API and intermediates.
Considering the needs of system for 21st century, this guideline should be implemented in accordance with the current approaches of Risk Management, Life cycle approach and system promoting continual improvement.

OBJECTIVE :
An objective of this training program is to explain this guideline in Global Approach.

CERTIFICATE :
Certificate will be awarded to the participants after successful compliance of the test at the end of the training programme.

FACULTY
Dr. Milind Pathak – (&) 09377434079, Email : niketan35@yahoo.co.in
* Having 29 years of experience in reputed APIs manufacturing industries at various capacities in QA and Regulatory Department.
An objective of this training program is to explain this guideline in Global Approach.

DATE & TIME :
19th & 20th August – 2016 : 9.00 A.M. to 5.00 P.M.
VENUE:
Hotel Lords Plaza, Station Road, Surat., Gujarat.

SCHEDULE : Day 1
9.00 AM                  Registration
9.15 AM                  Inauguration / Prayer
9.30 AM                  Introduction
9.45 AM                  Scope, Application & Principle
10.00 AM                Responsibilities (All the concerned departments)
11.15 AM                Tea Break
11.30 AM                Product Quality Review (Use of Statistical Inputs and tools for continual                                  improvement)
12.45 PM                Building & Facility (Risk based approach).
1.00 PM                  Lunch
1.45 PM                  Calibrations, Documents & Records (Data Integrity)
3.15 PM                  Tea Break
3.30 PM                  Materials Management & Manufacturing controls (PAT)
5.00 PM                  Day off

SCHEDULE : Day 2
9.00 AM                 Storage & distribution
9.15 AM                 Laboratory controls (Data Integrity)
10.30 AM               Qualification of equipment
11.00 AM               Tea Break
11.15 AM               Validations : Life cycle approach
1.00 AM                 Lunch
1.45 PM                 Validations (contd.)
2.15 PM                 change Control & Deviations (Risk based approach)
3.00 PM                 Tea Break
3.15 PM                 Complaints & Recalls (Investigation for improvement)
3.45 PM                 Summary
4.00 PM                 Evaluation Test
4.15 PM                 Valedictory Function Distribution of certificates
5.00 PM                 Closure.

FEES :
Training charges : 4,500/- Rs. per participant + Service Tax 15% (675/-Rs.). Total : 5175/-.

DISCOUNT
10% Discount for QCFI-Life Members. 5% Discount for 3 or more participants from QCFI – Institutional Member organizations.

SPECIAL OFFER:
5% Special discount on training charges will be offered for early birds, registration and payment of charges on or before 9th August – 2016.

ENROLLMENT
Registration can be acknowledged on niketan35@yahoo.co.in or qcfi.ank@gmail.com
Cash or Draft or Cheque can be sent in favor of “Quality Circle Forum of India” and can be submitted at following address

QUALITY CIRCLE FORUM OF INDIA
Ankleshwar Chapter
Opp. State Bank of India (Main Branch), Chauta Naka,
Station Road, ANKLESHWAR – 393 001