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2-Day Seminar by  with Dr. Ludwig Huber

The seminar was organized by Global CompliancePanel and was held at the JW Marriott Renaissance Hotel Mumbai, India. It was attended by 170 professionals who came , from all parts of India but also from other countries in Asia. They came from API manufacturers and pharmaceutical companies, from contract laboratories and food industry but also from public institutes and universities. They represented QA, QC , and IT/IS management and senior staff..

Seminar format

The program was dedicated to quality assurance, IT/IS, manufacturing, quality control laboratories and regulatory affairs and provided an excellent opportunity to senior staff, middle and senior management of pharmaceutical, API and medical service companies but also for software and related service providers to learn about US FDA and EU requirements for electronic signatures and part 11 compliance and signatures. Practical examples, case studies and interactive exercises have been dispersed into and between the presentations. About 50% of the total time had been dedicated to interactive discussions and practical sessions with life examples. On both days the questions and discussions with went on between breaks and long after the official agenda had been finished..

The Organizer - GlobalCompliancePanel

GlobalCompliancePanel is a training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in user friendly formats. The company offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts, discussion forums, public seminars and on-site trainings.

GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:

• Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations

• Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs

• One stop destination for all your queries and to share and discuss issues, ideas and best practices and

• A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.

NetZealous LLC DBA Global Compliance Panel is headquartered at 1000 N West Street | Suite 1200 | Wilmington | DE 19801.

Seminar Objectives

• Get an in depths understanding about computer system validation understanding and electronic records & signatures
•  Receive and understand master plans, step-by-step implementation plan, case studies and fill-in templates to easily develop documents as required by FDA and international agencies
• Learn through workshop exercises and interactive discussion sessions how to manage and implement computer validation and e-records & signature compliance projects, e.g., ensuring data integrity and security.
• Learn from Dr. Ludwig Huber's over 20 years industry experience in regulatory FDA and international compliance

Agenda

The seminar consisted of 8 modules with 4 modules being held on both days.

Module 1: Regulatory requirements and recommendations from Industry Task Force

• FDA and EU requirements for software and computer system validation
• FDA Inspection and Enforcement Practice
• Examples of recent FDA Warning Letters and 483s
• Which systems need to be validated
• Computer validation according to GAMP 5
• Selecting the right validation approach for commercial off-the-shelf system
• Developing a validation master plan
• How to keep validation costs under control
• Using the risk based validation approach to lower costs

Module 2: Eight Steps for Cost Effective Computer System Validation

• Forming the validation team: Selecting the right members and a project leader
• Writing meaningful specifications
• Planning for effective implementation
• Risk assessment
• Selecting and qualifying the right vendor using the risk based approach
• Preparing the site for installation
• Installing and testing the system for correct operation
• Testing during on-going use: what and how
• Writing the summary report
• Validating existing systems
• Change control and revalidation

Module 3: Initial and ongoing tests of software and computer system

• 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

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: 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
• History, current status and future of Part 11 and Annex 11
• Difference and similarity between Part 11 and Annex 11
• FDA inspection and enforcement practices of electronic records: examples of recent FDA warning letters, with focus on data integrity and security.
• The difference between electronic and digital signatures
• E-signature requirements for Annex 11 and Part 11

Module 6: Steps to Implement Part 11 to Ensure Data Integrity and Security

• 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
• 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
• What to archive for hybrid systems: paper records or electronic records
• Justification and documentation your approach towards Part 11/Annex 11
• Raw data: Definition, acquisition, maintenance and archiving
• Cross check: Does the designed system meet requirements for Data Integrity and Security
• Required procedures to ensure data integrity, security and availability.
• Going through model case studies

Module 7: Validation and Use of Excel Spreadsheets in Regulated Environments

• FDA/EMA requirements and enforcement practices for spreadsheets
• Recommendations from GAMP®5 for Excel
• 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?
• Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody

Module 8: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
• What to do with new security patches
• Going through a real life inspection
• Using the internet in regulated environment
• How to deal with virtual systems and cloud computing

Hands-on Workshop Exercises and Interactive Discussions

The make seminar exercises very effective attendees did get fill-in templates.

1. Define which users need to be validation
2. Define high - medium and low risk computer systems
3. Define requirements for computer systems
4. Define vendor requirements for computer systems
5. Define test requirements for computer systems
6. Define revalidation activities for validation of computer systems
7. Define steps for retrospective validation of computer systems
8. Define steps for handling test deviations of computer systems
9. Define steps for reviewing computer systems
10. Define audit items for computer systems
11. Define raw data of hybrid systems on laboratory, manufacturing and office computers.
12. Define procedures to specify, implement, validate, record and review electronic audit trails
13. Define technical computer requirements and procedures to ensure data integrity and security
14. Define requirements specifications for Part 11 compliant Excel spreadsheets               
15. Define tests for Excel spreadsheets
16. Define requirements specifications for networks
17. Define tests for PC Clients, Data Centers and Servers
18. Define activities after software and computer system changes
19. Define and document steps for Part 11 implementation

Reference documents for easy Implementation

Attendees did get free access to a Labcompliance website with free reference material for immediate downloads. The material will help attendees to easily implement what they have leaned during the workshop.

• Computer System Validation Master plan (56 pages with templates)

• Primer: Computer System Validation (46 pages)

• Computer System Validation: Step-by-step implementation (10 pages)

• 21 CFR Part 11 Compliance Master Plan

• 21 CFR Part 11 - Step-by-Step Implementation

• 21 CFR Part 11  Implementation - 15 Case Studies

Six Lucky Winners and 50% Discount for the Labcompliance Computer System Validation Package

Labcompliance did sponsor six Labcompliance Computer System Validation Packages for a Lucky Draw at the end. In addition, three volunteers reporting about their group workshop exercises received the package with a value of $599.-The not so lucky ones still can get the package for an attractive 50% discount.

The seminar has been attended by 170 professionals

Senior staff, middle and upper management including:

•  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

Attendees came from

• International and local pharmaceutical industry
• API manufacturers
• Medical Device industry
• Software providers
• Service providers
• Contract laboratories
• Consulting Companies

About the speaker: Dr. Ludwig Huber

• Director for global FDA compliance and chief advisor at www.labcompliance.com , the global on-line resource for validation and compliance issues.
• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
• Received the first GLP Award of the Indian Drug Manufacturing Association.
• Presenter of the Year selected out of 175 speakers by delegates of the IIVT conferences.
• Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
• Member  of the Scientific Advisory board of IVT’s GxP and Validation Journals,
• Dr Huber 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, PIC/S, PDA, GAMP, ISPE, USP and several national health agencies in Singapore, Korea, US-FDA, Thailand and China.
• For more information on Ludwig Huber, click here.

Each of the 170 available chairs were occupied when Dr. Ludwig Huber presented the seminar agenda at 9.30 a.m..

Selected photos with annotations 

	The J.W. Marriott Renaissance Mumbai Convention Centre Hotel at the Powai Lake provided excellent  conference facilities and  environment  for the event.
	Long before the seminar started attendees arrived at the Marriott Renaissance hotel.
	Seminar program director Mr. Liju Mathew smiled with 170 attendees coming.  He was very proud of his team!
	The program agenda was displayed on a huge board in the reception hall. With this convenience delegates never missed the sessions
	All delegates were in the conference hall in time not to miss anything.
	Show master Leena Chavan opened the seminar at 9.00 a.m. She introduced the speaker - Dr.Ludwig Huber (Doubleclick on the picture to view the video)
	Dr Ludwig Huber explained the agenda, the interactive format and the free reference material.
	Each of the 8 modules ended with a Q&A sessions. They lasted between 15 minutes and one our.
	Delegates could also submit written questions. Ms. Chavan did read them for the audience and Dr. Huber..
	Discussions have been quite interactive and lively
	Delegates could enjoy excellent food and drinks in morning, lunch and afternoon breaks.
	Delegates also used the break to share their experience with computer system validation and Part 11 compliance.
	Right from the start delegates took the opportunity to get photographed with Dr. Ludwig Huber.
	Ms. Chavan opened the next session, reminding the audience to focus verbal questions to more generic topics and submit specific questions in writing, or to use the breaks for discussions with the speaker.
	Dr. Huber helping this table with the workshop exercises
	Many times delegates had follow-up questions. But at the end everything was clear.
	A frequent question was on how detailed User Requirement Specifications should be.
	In the lunch break the Global CompliancePanel management introduced Dr. Huber to the Sponsors and Media Partners.
	During the interactive discussion sessions the delegates had many questions, mainly to validation and dat integrity issues..
	Also long after official program was finished delegates still had  many detailed and very specific  questions. Dr Huber answered them all.
	Global- CompliancePanel displayed some of the most successful  Webinar CDs presented by Dr. Huber. They were offered just to the delegates at attractive discount.
	The moderator and speaker are ready for the next session, the audience is eagerly waiting for what's  next
	Dr. Huber was always close to the audience, facilitating the interactive format.
	One of the popular questions was on how to validate Virtual Software and Cloud Computers
	During the break seminar attendees were asked to give feedback on video.
	Practical examples, case studies and interactive exercises have been dispersed into and between the presentations.
	All attendees worked to complete the workshop tasks. Here the task was to define, justify and document Part 11 compliance, mainly to ensure data integrity..
	Does the system has to comply with Part 11 and if yes, with which function?
	There are still some doubts about the Part 11 system requirements
	Team delegates presented the workshop results, and received the Labcompliance Computer System Validation Package
	Dr. Huber handing over  Prizes sponsored by Global CompliancePanel
	Dr. Huber with the 3 winners of the Prize sponsored by Global CompliancePanel
	Delegates taking photos of the speaker.
	Ludwig Huber with some winners of the prizes: Labcompliance Computer System Validation Package (value $649.-) and a gift from Nichepre.
	Done!!! Two happy faces at the end. Show Master and Speaker
	I would like to thank Global- CompliancePanel for inviting me to present this workshop and for superb organization, Leena for smart moderation and  all attendees for great discussions. Ludwig Huber

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