CSV Deliverables explained well.

1. GAMP 5 & 21 CFR Part 11 Compliance
With Computer System Validation
Course Objectives:
Using the GAMP® Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and
Signatures as a resource, this course will give participants a practical introduction to the 21 CFR Part 11
regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-
the-minute information on the status of FDA's current re-examination of the regulation, including a
discussion of the Agency's latest Part 11-related guidance and inspection assignments. Taught through
classroom presentations, workshop sessions, and team exercises, the course will present an overview of
Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed
analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry
issues.
A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11
compliance, as well as compliance with other international regulations covering electronic records and
signatures. The GAMP Guide provides timely and much needed direction on meeting current regulatory
expectations for compliant electronic records and signatures. The Guide describes how a risk
management approach may be used to ensure the compliance of regulated electronic records and
signatures, through the application of appropriate controls commensurate with the impact of records and
the risks to those records.
Data Integrity issues are like Diabetes it is not hard to controlled by better life style. If not controlled it can
be source of many diseases when combined with other diseas attack. Now as full GMP slowly coming to
computers Data Integrity issue has become like Diabetes. If not controlled it can harm ever where and it
can be dangerous. Only way to control is to live controlled and better compliance life style and
medication (Training in case of data Integrity from Good Trainer). Wish you all the best. Today is my
birthday and decide to help pharma industry a lot.
Please start Independent Third party Audit of Data Integrity. It can help reduce 483 and warning letter by
great amount.
When we see lot of company getting 483 and warning letter. We feel real bad.
nd rd
02 - 03 June 2016 th th
06 - 07 June 2016
Mumbai Chandigarh
info@marcepinc.comwww.marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
Two Day Pharma Conclave:
since: 1980
training the professionals
R

2. Why Validation ?
Validation Documentation
21 CFR Part 11 Compliance in Details, Data Integrity and
Security. Basic and Advance Two Session
Why the need for Validation came in to picture. History Of
Validation
Benefits of Validation
V Module
How we can get Good System
Validation Definition
GAMP4 V/S GAMP5
Types of Validation Prospective, Concurrent and
Retrospective.
Validation Plan and Validation Report
Supplier Agreement
Vendor Assessment Report
GAMP5 Basics
GAMP5 Drivers
Software and Hardware category as per GAMP5
Main points
Legacy System
Open System
Close System
Electronic Records
Hybrid Systems
Electronic Signature
Digital Signatures
Black box
White box
Data backup – Restoration, Archival- Retrival and data
Retention.
Annex 11
Data Integrity and Security
ALCOA
Maintenance Qualification
Basic Concepts of CSV
Advantages of Validation If time permits
Steps for CSV If Time permits
Risk Assessment
How validation helps to improve your business
Computer Validation as per GAMP5
Why Validation ? Deliverables of the Validation
VMP, URS, FS, DS, IRA, FRA, IQ, OQ, PQ, TRM, SR.
Using risk based approach for CSV
Benefit of Risk Assessment
Formation of Validation Team
Why to Write meaningful specifications/requirements
(URS)
Deliverable SRS, GXP Assessment, Risk Assessment, IQ,
OQ, Traceability Matrix, Summary Report
Risk Assessment Sod, RPN no.
Selecting and qualifying the right vendor – Risk Based
Approach as per GAMP category
Installing and testing the system for correct operation
Validation of existing system
Revalidation
Vendor Qualification, SLA
Difference between Qualification and Validation
Basic Understanding
Various types of Risk Assessment method
Example
Benefit of risk assessment in large project
GAMP 5 & 21 CFR Part 11 Compliance
With Computer System Validation
nd rd
02 - 03 June 2016 th th
06 - 07 June 2016
Mumbai Chandigarh
info@marcepinc.comwww.marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
Two day training modules:
Day One Day Two
Two Day Pharma Conclave:
since: 1980
training the professionals
R

3. GAMP 5 & 21 CFR Part 11 Compliance
With Computer System Validation
nd rd
02 - 03 June 2016 th th
06 - 07 June 2016
Mumbai Chandigarh
info@marcepinc.comwww.marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
Two Day Pharma Conclave:
Kalpesh R Vaghela
Software Validation Specialist. Expert Trainer on Electronic EBMR and EBPR, GAMP5, 21
CFR Part 11 Compliance, ICH Q9 Risk Assessment.
CEO Infra Control Systems & Founder Partner, KVS Technologies. Manufacturer of Automation and Software Validation and
Calibration Service Provider Company
Helping Indian and International Pharma Company achieve Compliance, Train and Motivates Staff for Right First Time
Approach. Quality by Design, built inside the subconscious of the production and Quality team.
Seventeen years of work experience with India’s Major Pharma Company, Seven year dedicated experience in software
validation.
Validation/ Risk Assessment jobs carried out in USA, Europe, China, Middle East and Africa.
Regarded as authority in the fields of Validation and Calibration.
Supported many USFDA, MHRA, ANVISA, MCC, TGA Customer Audits as a consultant.
Expertise in:
Please go to page 18-19 and 22.
If you still want more evidence visit company website and and you will see references from
all great people. Call any good quality person and he will have only one name in mind as far as validation is concern and that
is we. We train people and we do actual work so our training helps sharpening the saw.
Our Expertise
1) Computer Systems Validation for Manufacturing Area
2) Computer Systems Validation for Laboratory Area and Instruments
3) CSV Validation for all types of ERP – SAP Systems
4) CSV Validation for BMS Systems
5) CSV for Document management – Learning management Systems
6) CSV for EBMR and EBPR as well as MES Systems
7) CSV for Excel Validation
8) CSV for Clinical Research Software
9) Audit and GAP Analysis for 21 CFR Part 11 Compliance and Annex 11 Compliance
10) Fool proof System owner job validation like Data Integrity, Backup – restoration, Archival- retrieval – data Retention
and Migration check.
11) Compliance Training on Why Validation ? , Role of FDA, 21 CFR part 11 Compliance, Annex- 11, GAMP5, Risk
Assessment, CSV Deliverables, Data Integrity.
Point 11 is of ultimate importance on which many company do not focus. I bet that if all staff is given training on Data Integrity
and Compliance the return to the company will be multifold.
We have successfully worked in USA, Europe, Ireland, Ice Land, China, South Africa, Middle East and now gearing up to serve
the whole world in a big way. Best quality services at reasonable price and true positive surprise to client by good quality,
accurate and timely work is our motto. If you are looking for the good partner who can help you in producing quality product, it
is a time to give us a call at +919825047998, 8758217198. Wirte to ,
You can trust us for USFDA, MHRA, TGA, ANVISA, MCC and other critical Audit.
One look at our website references will give you clear idea about our capability. Please get in touch to know more about our
services. We can provide most of the services you need. We are famous for successful execution of the same.
Good CSV can help you Reduce CAPA, Change Control, Batch Recall and give all people on earth a good Peace of mind
including your shareholders. Data Integrity, Security, Patient safety and Product Quality is a key thing.
we are regarded as No.1 software validation company of India with presence in India and abroad. 80% of Top Pharma
Company is client of Infra Control Systems or KVS Technologies. Good Care needed to be taken while selecting the Software
validation consultant in checking their Facility, Company Management, Management Goals, Ranking Industry wise and
Pharma Sector Wise, Experience of working with Top companies of the world, Vision and Team strength.
We have tie up with world renowned team like Premier Validation UK , FDASmart , Life Science Expertise - France, Atachi
USA (MES) , Learn About GMP Online Platform from USA and many more..
We have proved our merits time and again.
www.kvstech.com www.infraics.in
infraics@yahoo.com kvstech7@yahoo.co.in