USFDA India Seminar 2011 at Mumbai

Dr.Ludwig Huberby

On 15th and 16th September , 2011 at Renaissance by J.W Marriott at Mumbai

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VALIDATION AND 21 CFRPART 11 COMPLIANCE OFCOMPUTER SYSTEMS

Dr.Ludwig HuberDirector of Labcompliance

The concept

ž 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive

discussions

USFDA India Seminar 2011 at Mumbai

About Speaker:

Dr. Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of

www.labcompliance.com, the on-line resource for validation and global FDA compliance. He is also the author of the

bestselling books “Validation of Computerized Analytical and Networked Systems ” and “Validation and Qualification in

Analytical Laboratories,”. Currently, Dr. Huber is on the Scientific Advisory board of IVT´s GxP and Validation Journals,

and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This

included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. Dr. Huber

also received the “First International GLP Award” from Indian Drug Manufacturer Association for presentations and

publications about GLP and GMP

September 15th and 16th, 2011Renaissance by J.W Marriott at Mumbai#2 & 3B, Near Chinmayanand Ashram, Powai.Mumbai, 400 087 India Contact number: 000 800 440 1180

Date and Venue:

Past Seminars

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Seminar Content: Conference timings: 9:00 am - 6:00 pm

Day 1 - 15th Sept 2011 Day 2 - 16th Sept 2011

USFDA India Seminar 2011 at Mumbai

Module 1: Regulatory requirements and recommendations from Industry Task Forces

> FDA and EU requirements for software and computer system validation

> FDA Inspection and Enforcement Practice How does validation help to improve your business

> Examples of recent Warning Letters and 483s

> Computer validation according to GAMP 5

> Which systems need to be validated

> Selecting the right validation approach for commercial off-the-shelf system

> Using the risk based validation approach to lower costs

> Step-by-step instruction for risk assessment according to most recent guidelines

> Workshop Exercises

Module 2: Eight Steps for Cost Effective Computer System Validation

> Forming the validation team: Selecting the right members and a project leader

> Planning for effective implementation

> Writing meaningful specifications

> Selecting and qualifying the right vendor using the risk based apprach

> Preparing the site for installation

> Installing and testing the system for correct operation

> Testing during on-going use: what and how

> Validating existing systems

> Change control and revalidation

> Workshop exercises

Module 3.Initial and ongoing tests of software and computer systems

> How to reduce costs though risk based testing using the traceability matrix

> Justify and document what and how much to test

> Leveraging vendor testing

> Understanding FDA warning letter phrases: testing for worst cases, high load, limit

> Testing COTS systems according to GAMP V

> Developing a test plan and protocols

> Required training documents of IT professionals and test engineers: don't forget GMP training

> How to conducting and document tests: demonstrating test evidence

> Review and approval of test protocols

> Handling deviations

> Workshop exercises

Module 4: Minimum Validation Documentation Inspectors want to see

> Why are the validation plan and validation report the most important documents

> Supplier agreement

> Supplier assessment reports

> Change control procedures and change control logs

> Back-up and archiving strategy

> Evaluation and review of computer systems

> Internal audit records versus reviews

> Contingency Plan

> Disaster recovery plan

> Reduce validation costs by using easy to understand and use fill-in blank validation documents

> Going through examples and fill-in templates

Module 5: Validation and Use of Excel Spreadsheets in regulated environments> Regulatory requirements for spreadsheets; FDA Part 11, PIC/S Good

Practice Guide. and the EU Annex 11 > Recommendations from the new GAMP®5 > How does FDA use Excel to comply with its own regulations: going through

two FDA information bulletins> How to design spreadsheets for compliance.> The reduced lifecycle for cost effective validation> How to ensure and validate spreadsheet integrity.> When, what and how much to test?> Validation of standard/native Excel functions? > Specifics of Excel spreadsheets and Macro programs> Excel spreadsheet validation from beginning to the end: A case study that

can be used by everybody

Module 6: Qualification of Network Infrastructure and Validation of Networked Systems> Why to qualify infrastructure if we validate the system anyway> Recommendations from FDA and GAMP> Configuration management and change control as the most important

network qualification steps> Qualification of PC clients, servers, data centers > What and how much to test with the risk based cost/benefits in mind: > Qualification of network components, servers, PC clients, > Documentation requirements: SOP, installation and test scripts, system

diagrams, change logs> Going through a real life inspection> Using the internet in regulated environment> Workshop exercises

Module 7. Understanding the spirit and basics of the FDA Part 11 and the EU GMP Annex 11> FDA and EU requirements for electronic records and signatures: similarity

and differences > FDA inspection and enforcement practices of electronic records: examples

of recent FDA warning letters> History, current status and future of Part 11 and Annex 11 > The difference between electronic and digital signatures> E-signature requirements for Annex 11 and Part 11> Deciding which systems require Part 11/Annex 11> Define user requirements for Part11/Annex 11 based on risk> Performing a Part 11 gap analysis> Upgrading old or purchasing new systems: compliance and business

aspects> Six steps for risk based implementation of Part 11/Annex 11

Module 8. Learn how to ensure and document data integrity for Part 11/EU Annex 11 Compliance > What to archive for hybrid systems: paper records or electronic records> Justification and documentation your approach towards Part 11/Annex 11

documentation> Raw data: Definition, acquisition, maintenance and archiving > Defending data security and integrity> Audit trail: the most important function to demonstrate data integrity> FDA expects to review audit trails: who, what, how many times> When do we must keep e-records after print out: 5 eye opening case

studies> Auditing computer systems for Part 11/Annex 11 compliance> ‘Must’ documents you must have for FDA/EMA Part 11/Annex 11

inspections> Going through model case studies> Workshop exercises> Final discussion and wrap-up

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How to Register:

Step 1: Download the registration form from GlobalCompliancePanel website.

Step 2: Fill in the requested information and fax us or email a scanned copy of the same.

Step 3: Send us the cheque with the purchase document which comes with the registration form.

Step 4: We will send you a confirmation letter within 1 week after we receive the check.

Step 5:Bring the confirmation letter with you on the 1st day of the seminar and submit it at the

registration counter to receive your seminar kit and join the seminar.

Contact Information:Ask for Suraj

Coordinator – India Seminar

Toll free: 1800 425 9409

Phone number: +91 80-2642-1482 / +91 80-3201-4957 / +91

80-3221-3341.

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Kindly get in touch with us for any help or information.

Look forward to meeting you at the seminar

Team GlobalCompliancePanel

USFDA India Seminar 2011 at Mumbai

1. Learning Objectives

2. Participation certificates

3. Interactive sessions with the US expert

4. Post event email assistance to your queries.

5. Special price on future purchase of web based trainings.

6. Special price on future consulting or expertise services.

7. Special price on future seminars by GlobalCompliancePanel.

8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,

notepad and pen.

9. Networking with industry's top notch professionals

Companies that will benefit:— Pharmaceutical development and manufacturing

— Active pharmaceutical Ingredients Industry

— IT/IS Service providers

— Contract laboratories

— Medical device companies

— CROs

— CMOs

Pricing List:

Seminar Charge

Standard Price: 16,000 + 10.3% Tax

Seminar + Hotel Charge

Ÿ 2 nights Stay

Ÿ Check in September 14th after 3 pm

Check out September 16th before 6 pm

Ÿ Seminar fee, 2 way Airport transfers,

Buffet breakfast, Networking tea breaks,

Buffet Lunch & all taxes

Standard Price: 32,995

10% discount on seminar fee for a

group of 5 or more.

Professionals who will benefit: ž Directors

ž IT/IS managers and system administrators

ž QA managers and personnel

ž QC and Lab managers

ž Validation specialists

ž Software developers

ž Regulatory affairs

ž Training departments

ž Documentation department

ž Consultants

What you get: