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

Net Zealous

Dr.Ludwig HuberDirector of Labcompliance

The concept

?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 12th, 13th and 14th, 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 Forcesu? FDA and EU requirements for software and computer system validation u? FDA Inspection and Enforcement Practice How does validation help to

improve your businessu? Examples of recent Warning Letters and 483su? Computer validation according to GAMP 5u? Which systems need to be validatedu? Selecting the right validation approach for commercial off-the-shelf systemu? Using the risk based validation approach to lower costs u? Step-by-step instruction for risk assessment according to most recent

guidelinesu? Workshop Exercises

Module 2: Eight Steps for Cost Effective Computer System Validationu? Forming the validation team: Selecting the right members and a project

leader u? Planning for effective implementationu? Writing meaningful specificationsu? Selecting and qualifying the right vendor using the risk based apprachu? Preparing the site for installation u? Installing and testing the system for correct operation u? Testing during on-going use: what and howu? Validating existing systemsu? Change control and revalidationu? Workshop exercises

Module 3.Initial and ongoing tests of software and computer systemsu? How to reduce costs though risk based testing using the traceability matrixu? Justify and document what and how much to testu? Leveraging vendor testingu? Understanding FDA warning letter phrases: testing for worst cases, high

load, limit u? Testing COTS systems according to GAMP Vu? Developing a test plan and protocolsu? Required training documents of IT professionals and test engineers: don't

forget GMP training u? How to conducting and document tests: demonstrating test evidenceu? Review and approval of test protocolsu? Handling deviationsu? Workshop exercises

Module 4: Minimum Validation Documentation Inspectors want to seeu? Why are the validation plan and validation report the most important

documentsu? Supplier agreementu? Supplier assessment reportsu? Change control procedures and change control logsu? Back-up and archiving strategyu? Evaluation and review of computer systemsu? Internal audit records versus reviewsu? Contingency Planu? Disaster recovery planu? Reduce validation costs by using easy to understand and use fill-in blank

validation documentsu? Going through examples and fill-in templates

Lecture 5: Equipment

Qualifications

uThe USP definitions and

procedures.

uAnalytical Instrument

Qualification (AIQ)

uPart 11 and Computer Validation

Lecture 6: Test Method Validation,

Part 1

uDefinitions

uMethodology and statistics

Lecture 7: Test Method Validation,

Part 2

uMethodology and Statistics

uHandling the different types of

test methods

uInput from the Guidance on

Process Validation

Lecture 8: Process Validation

uThe guidance documents, Part 1

?Definitions

?Stage 1 – Process Design

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

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

two FDA information bulletinsuHow to design spreadsheets for compliance.uThe reduced lifecycle for cost effective validationu? How to ensure and validate spreadsheet integrity.uWhen, what and how much to test?uValidation of standard/native Excel functions? uSpecifics of Excel spreadsheets and Macro programsuExcel spreadsheet validation from beginning to the end: A case study that

can be used by everybodyModule 6: Qualification of Network Infrastructure and Validation of Networked SystemsuWhy to qualify infrastructure if we validate the system anywayuRecommendations from FDA and GAMPuConfiguration management and change control as the most important

network qualification stepsuQualification of PC clients, servers, data centers uWhat and how much to test with the risk based cost/benefits in mind: uQualification of network components, servers, PC clients, uDocumentation requirements: SOP, installation and test scripts, system

diagrams, change logsuGoing through a real life inspectionuUsing the internet in regulated environmentuWorkshop exercisesModule 7. Understanding the spirit and basics of the FDA Part 11 and the EU GMP Annex 11uFDA and EU requirements for electronic records and signatures: similarity

and differences uFDA inspection and enforcement practices of electronic records: examples

of recent FDA warning lettersuHistory, current status and future of Part 11 and Annex 11 uThe difference between electronic and digital signaturesuE-signature requirements for Annex 11 and Part 11uDeciding which systems require Part 11/Annex 11uDefine user requirements for Part11/Annex 11 based on riskuPerforming a Part 11 gap analysisuUpgrading old or purchasing new systems: compliance and business

aspectsuSix steps for risk based implementation of Part 11/Annex 11Module 8. Learn how to ensure and document data integrity for Part 11/EU Annex 11 Compliance uWhat to archive for hybrid systems: paper records or electronic recordsuJustification and documentation your approach towards Part 11/Annex 11

documentationuRaw data: Definition, acquisition, maintenance and archiving uDefending data security and integrityuAudit trail: the most important function to demonstrate data integrityuFDA expects to review audit trails: who, what, how many timesuWhen do we must keep e-records after print out: 5 eye opening case

studiesuAuditing computer systems for Part 11/Annex 11 complianceu‘Must’ documents you must have for FDA/EMA Part 11/Annex 11

inspectionsuGoing through model case studiesuWorkshop exercisesuFinal 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

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

+91 80-3221-3341.

Email: customersupport@globalcompliancepanel.com

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4th Floor, A, Block, Brigade Software Park,

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Bangalore-560070. INDIA.

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

What you pay:

Professionals who will benefit: ?Directors

?IT/IS managers and system administrators

? QA managers and personnel

?QC and Lab managers

? Validation specialists

? Software developers

?Regulatory affairs

?Training departments

? Documentation department

?Consultants

What you get:

For attractive

package

to stay at

Renaissance by

J.W Marriott

at Mumbai

please call us!

1. Price for One Delegate pass – INR

16000 + 10.3% tax

2. Early bird price for one Delegate pass –

INR 14000 + 10.3% tax

3. Group Delegate pass (5 & above) – 10%

discount on total amount.