INTRODUCTION This summit outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred to in this training summit as drugs. This training summit incorporates principles and approaches that all pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations after attending the course.

1. QUALIFICATION & VALIDATION
AND
QUALITY SYSTEM DOCUMENTATION SUPPORT
International Pharmaceutical Summit
th th
11 - 12 August 2017
Mumbai
Three Course Directors:
Hitendra Pandit - Exp. 38 years
Mukesh Shah - Exp. 36 Years
Praveen Dhandhusaria - Exp. 40 Years
R
An ISO 9001:2015 CERTIFIED COMPANY
Let’s make your pharmaceutical asset safe & better !
For registration & enquiries contact Mr. Pratik on: pratik@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.cominfo@marcepinc.com Cell: 7506478878
We will be proud to become your in house training & business consultancy partner for your workforce & plant
development. For any tailor made training’s or consultancy at your Pharmaceutical Facility in any vertical just
email us on: hema@marcepinc.com or raj@marcepinc.com
This summit will represent the FDA’s,
EMA and Global Regulator Agencies
requirements & current thinking on
this topic.
INTRODUCTION
This summit outlines the general principles and approaches that FDA considers appropriate elements of
process validation for the manufacturing of any pharmaceutical product, including APIs or drug item, referred
to in this training summit as drugs. This training summit incorporates principles and approaches that all
pharmaceutical manufacturers can use to validate manufacturing processes in their respective organizations
after attending the course.
Q&V Compliance
2017

2. 09:00 to 09:30 Breakfast & Tea/Coffee
09:30 to 11:00
11:00 to 11:15 Tea/Coffee
11:15 to 12:45
Validation Master Plan (VMP)
Documents Equipment Qualification
Handling Validation Team
12:45 to 14:00 Lunch Break
14:00 to 15:30
Recent Trends for Good Data and Record Management
Data integrity & what it means to have ALCOA data
Meeting ALCOA expectations on electronic records
15:30 to 15:45 Tea/Coffee
15:45 to 17:15
17: 15 to 17:30
Quality Management System
Good Documentation Practices
Data Integrity & Principles of ALCOA
FDA 483 Case Studies
Question / Answer Session
Day - One
Day - Two
Two day training agenda
For registration & enquiries contact Mr. Pratik on: pratik@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.cominfo@marcepinc.com Cell: 7506478878
09:00 to 09:30 Registration, Breakfast & Tea/Coffee
09:30 to 11:00
Europe
FDA
Global harmonization and expectations
11:00 to 11:15 Tea/Coffee Break
11:15 to 12:45
Concept of Process Validation
Learn How & why of Process Validation
Process Validation is a GMP and Statutory requirement
Process validation helps understand your processes and minimizing Process problems
12:45 to 14:00 Lunch Break
14:00 to 15:30
Why cleaning is necessary after manufacturing ?
Cleaning is a part of manufacturing process
Cleaning is GMP and regulatory requirement
Achieve more confidence in your product Quality & Purity through cleaning validation
15:30 to 15:45 Tea/Coffee Break
15:45 to 17:15
European Medicines Agency (EMA) and the FDA Regulatory Requirement
Equipment Qualification Requirement
Process Validation
Cleaning Validation
Computer System Validation
Cleaning is a high profile issue with FDA because of product contamination due to
uncontrolled and non validated cleaning process.
Process validation data are required at preregistration stage in some Countries during.
Submission of application for marketing authorization.
Quality Management Systems is a prerequisite for any Pharmaceutical
Organization to comply with the stringent regulatory requirements like cGMP,
WHO GMP, MCA.
Well established quality management system will ensure no complaints & product
recalls through continual improvement.
Achieve greater customer satisfaction and demand for export in International
markets through well practiced quality management systems.

3. Started his career from Sarabhai Group - Vadodara with an exposure to Quality Control, Research & Development
of Diagnostic Kits, Fermentation and Quality Assurance in 13 years of tenure.
He also got an opportunity to accept the challenging task in Quality Control of M. J. Pharmaceutical Ltd. (Now Sun
Pharmaceuticals) for another 09 years and elevated from time to time to accept higher responsibilities. Received
Technical training from Eli Lilly & Co. USA on Insulin Injectable formulations.
Have played main leading role in transfer of technology of various formulation in overseas joint venture companies
and audits of various Int. API & Formulation Facilities.
Started career as Chemist in January 1973 with Roche Products Limited, the Indian subsidiary of Hoffman La Roche,
Basel, Switzerland. Worked in QC & QAas Sr. executive till March 1995 getting good working experience in analysis of
materials, products and monitoring of processes in QA.
Joined new facility of IPCALaboratories Ltd., Athal, Silvassa, in April 1995 and worked as Manager QA till September
1999. Major thrust area was Qualification and Validation of Injectable & Oral Solid dosage facilities, systems &
processes. Made good contribution in achieving various approvals like WHO,TGA, MHRA, MCC (SouthAfrica) & ISO.
Joined Elder Pharmaceuticals Ltd., in October 1999 and worked till October 2015. Worked as Corporate DGM QAat
Nerul, Navi Mumbai facility for 10 years. Responsible for overall Quality operations of various manufacturing facilities
of Elder. (Four facilities in Navi Mumbai,Two facility in Selaqui Dehradun and one in Ponta Sahib, Himachal Pradesh)
Has extensive experience of 36 years of versatile exp. in all major Pharmaceutical Companies i.e. Sarabhai Research
Center, Ranbaxy Laboratories Ltd., IPCALaboratories Ltd., Piramal Healthcare Ltd. etc.
Tenure of service spanned through all aspects of Hard core QualityAssurance involved in manufacturing and controls
of Intermediates,APIs and pharmaceutical dosage forms. Viz. Tablets, Capsules, Liquid Orals, Dry Syrups, Injections,
externals etc., Besides hands on experience on state-of-the-art Product Development and modern analytical
instruments with data interpretation.
Successfully, faced several international customer(s) and regulatory audits including WHO, TGA, MHRA, USFDA etc.
With a good background of Vendor Qualification andAssurance.
Course Director: Mr. Hitendra Pandit
Course Director: Mr. Pravin Dhandhusaria
Course Director: Mr. Mukesh Shah
QUALIFICATION & VALIDATION
AND
QUALITY SYSTEM DOCUMENTATION SUPPORT
International Pharmaceutical Summit
th th
11 - 12 August 2017
Mumbai
The international regulatory agencies have expectations that pharmaceutical facilities will prove control over their production
equipments. The FDA's findings of failure concerning equipment validation signal the agencies expect deviative evidence that
the equipment qualification and validation schedules of a facility will control their production processes. Examples of FDA
warning letters 483 findings for equipment qualification and validation indicate failure in many of these studies.
In this two day summit you will learn the different order to develop and implement bulletproof solutions that are accepted,
effective, and efficient. Additionally, pharmaceutical case studies will explore how equipment qualification/ validation programs
and how the legal issues that arise from non-conformance with regulators and Auditors.
Understand what the global regulators expectations are for equipment qualification and validation.
Understand the documents required for equipment qualification and process validation.
Understand and know how to write and maintain a Validation Master Plan.
Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Qualify system management in regulatory environment.
Understand the different types of validation.
Know the guidelines on validating analytical methods
Support equipment qualification and validation through the quality management system, risk analysis, change control.
Understand and know the principles of auditing the equipment qualification and validation.
Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier.
Perform risk assessments effectively
Course Description
Learning Outcome:
For registration & enquiries contact Mr. Pratik on: pratik@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.cominfo@marcepinc.com Cell: 7506478878

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www.marcepinc.com
QUALIFICATION & VALIDATION
AND
QUALITY SYSTEM DOCUMENTATION SUPPORT
International Pharmaceutical Summit
th th
11 - 12 August 2017
Mumbai
R
An ISO 9001:2015 CERTIFIED COMPANY