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Attendees did get free access to a Labcompliance website with lot's of reference material. Examples included: Master plans checklists, examples,  SOPs, and USP presentations. The material will help to easily implement what they have leaned during the workshop.

 

 

All seminars come with 10+ best practice documents, such as SOPs, checklists, master plans

 

Validation and Use of Cloud Computing in FDA&EU Regulated Environments

Comply with GXPs, Part 11, EU/PICS Annex 11 and other regulations

Recorded, available at any time

 

Risk Based Validation of Computer Systems and Part 11 Compliance

With Strategies for FDA/EU Compliance and Tool Kits for effective implementations

Recorded, available at any time

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded, available at any time

 

Understanding and Implementing the New EU/PICS Annex 11

Learn about specific requirements and get tools for implementation

Recorded, available at any time

ecorded

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation

Recorded, available at any time

 

Learning from Recent Warning Letters related to Part 11 and Computer Validation

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Electronic Audit Trails for FDA Compliance
Requirements - Design - Implementation - Validation - Documentation

Recorded, available at any time

 

FDA's New Enforcement of Part 11

Learn what the FDA is looking for and how to respond

Recorded, available at any time

 

Ensuring Integrity of Laboratory Data for FDA/EU Compliance

With 10+ best practice guides for easy implementationss

Recorded, available at any time

 

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspection

Recorded, available at any times

 

Understanding the New FDA Data Integrity Guidance

With examples and procedures for effective implementation

Recorded, available at any time 

 

FDA Compliant IT Infrastructure and Network Qualification
With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Assessment of Software and Computer System Suppliers

Recorded, available at any time 

 

FDA Compliant Testing for Validation and Qualification

Recorded, available at any time 

 

Computer System Validation Master and Project Planning

Includes 10 SOPs and a master and project plan

Recorded, available at any time 

 

Configuration Management and Change Control for Networks and Computer Systems

Strategies for FDA Compliance and Tools for Implementation

Recorded, available at any time 

 

Retirement of Computer Systems

Strategies for FDA Compliance and Tools for Implementation

Recorded, available at any time 

 

FDA's New Guidance on using Computers for Clinical Trials

Understanding FDA's New Approach Towards Computer Systems

Recorded, available at any time 

 

Validation and Part11 Compliance of Chromatographic Data Systems

With 10 Validation Examples: From planning to system retirement

Recorded, available at any time 

 

Validation and Part 11 Compliance of Electronic Document Management Systems

With Validation Examples: From planning to system retirement

Recorded, available at any time 

 

Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance

Recorded, available at any time 

 

Writing Effective Test Scripts and Validation Protocols for the Bio/Pharmaceutical Industry

Recorded, available at any time 

 

Validation of Existing/Legacy Computer Systems

FDA/EU requirements and strategies and tools for implementation

Recorded, available at any time 

 

Master Planning for Software and Computer Validation

With examples for master and several project plans

 

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded, available at any time 

 

Validation and Control of Excel® Spreadsheets ifor FDA Compliance Comply with FDA Part 11, the PIC/s Good Practice Guide and the EU Annex 11

Recorded, available at any time 

 

 

                                           

Photos

Seminar feedback from attendees

2-Day Seminar by  Dr. Ludwig Huber

The seminar was organized by Global CompliancePanel and was held at the Leela Hotel Mumbai, India. On each day it was attended by 270+ upper and mid-range managers from lndian and international companies. They came from API manufacturers and pharmaceutical companies, from medical device manufacturers and contract laboratories  but also from public institutes and universities. They represented QA, QC , manufacturing, laboratory, IT/IS management and consultants..

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, and to middle and upper 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 records and signatures and about Part 11 compliance of computer systems. 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  went on during breaks and long after the official agenda had been finished.

According to a press release of the organizer, NetZealous, a Fremont, CA-registered organization, DBA GlobalCompliancePanel, this seminar was the company's best attended in-person seminar ever

The Organizer - GlobalCompliancePanel

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management

  • Regulatory Compliances

  • Corporate Governance

  • Quality Management.

Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.

Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till now.

In the course of providing world-class training to compliance professionals by compliance and consulting gurus, GlobalCompliancePanel is also:

  • A provider of information to ensure compliance and enhance quality with regulations for individuals as well as the organizations

  • A supplier of the latest updates on industry trends, industry best practices and any modifications in the regulatory affairs

  • A platform 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.

Seminar Objectives: Validation and Part 11 Compliance of Computer Systems and Data

  • Get an in depth 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 30 years industry experience in regulatory FDA and international compliance

Agenda

The seminar consisted of 8 modules with 4 modules being held on both days
At the end of each module there are Q&A sessions of approximately 15 minutes.

Module 1: Regulatory Requirements and approaches for instrument qualification, computer system validation and data integrity

  • FDA, EU and PIC/S requirements for software and computer system validation
  • Compliance concern with data integrity - some statistics: where, what, when
  • Lessons from recent FDA Warning Letters and how to avoid them
  • USP Chapter <1058> for analytical instruments: current and proposed changes
  • Understanding the terminology: qualification, calibration, verification, validation
  • Computer validation according to  GAMP®5
  • Which instruments/systems require qualification/validation
  • Planning for cost-effective qualification and validation
  • Developing a validation master plan

Module 2: Qualification of equipment: planning, DQ, IQ, OQ PQ, testing and deviation handling, reporting

  • Develop a project plan from the master plan
  • Writing requirement specifications
  • Documenting installation and installation qualification
  • Testing for initial operational qualification
  • Leveraging system suitability testing for on-going performance qualification
  • Preparing and executing test protocols
  • Preparing inspection ready documentation
  • Maintenance, requalification and change control

Module 3: Introduction to 21 CFR Part 11 and EU/PICS Annex 11

  • Objective, scope, current situation and future of Part11
  • Requirements overview and spirit of the regulation
  • Requirements for electronic records
  • Requirements for electronic and digital signature
    Additional requirements from the PICS/EU Annex 11, from the UK MHRA and from the WHO GMP data integrity guidelines
  • FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters
  • User requirements for Part11/Annex 11 based on risk
  • Upgrading old or purchasing new systems: compliance and business aspects
  • Six steps for implementation of Part11/Annex 11

Module 4: Validation of Computer Systems and Qualification of Network Infrastructure

  • Selecting the right validation lifecycle model
  • Going through examples of a complete computer system validation from beginning to end
  • How risk assessments can help to determine the type an extent of validation
  • Vendor assessment and supplier agreements
  • Testing and documenting installation, initial operation and ongoing use
  • Validation of existing equipment and computer systems
  • Integrating the GAMP® guide with USP <1058> for instrument and system validation
    IT infrastructure qualification and validation of networked systems
  • Validation and use of cloud computing in FDA/EU regulated environments

Modul 5: Validation and Use of Excel Spreadsheets Applications

  • FDA/EMA requirements and enforcement practices for spreadsheets
  • How does FDA use Excel to comply with its own regulations: going through two FDA information bulletins
  • How to design spreadsheets for compliance.
  • Dealing with audit trail requirements
  • 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 6: Maintaining the validated state of computer systems

  • System maintenance
  • Change control,
  • Periodic review
  • Revalidation
  • Disaster recovery and business continuity
  • Back up and archiving
  • Data migration to new sysgtems
  • Controlled system retirement

Module 7: Ensuring Integrity of (Raw) data and other records

  • Definition of raw data: FDA/EMA requirements
  • What to archive for hybrid systems: paper records or electronic records
  • The importance of electronic audit trail to document data integrity
  • Review of electronic audit trail: who, what, and how
  • How to ensure availability of electronic records throughout the entire retention period
  • Steps for validating security and integrity functions
  • Examples how to ensure and document data integrity and security

Module 8: Auditing systems and record for Part 11 / Annex 11 compliance

  • Using FDA Inspections as model for laboratory audits
  • Going through a typical FDA computer system inspection
  • Preparing inspection ready documentation
  • Avoid or respond to FDA 483s and warning letters
  • Going through the new FDA "Data Integrity for CGMP Compliance" in preparation for data integrity audits
  • Learning from recent FDA data integrity inspections

Hands-on Workshop Exercises and Interactive Discussions

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

  1. Define which systems need to be validated
  2. Define high - medium and low risk computer systems
  3. Define user requirements for Part 11 and Annex 11
  4. Define vendor requirements for Part 11 and Annex 11
  5. Define revalidation activities for validation of computer systems
  6. Define audit items for computer systems
  7. 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)
  • 21 CFR Part 11 Compliance Master Plan
  • 70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
  • 14 SOPs related to validation and qualification of equipment and computer systems, change-control, risk assessment, maintenance, security and integrity of electronic records
  • Full Set of qualification examples for an HPLC system
  • Full set of Validation examples of a Chromatography Data System
  • Full set of Validation examples of a document management Systems

The seminar has been attended by 272 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 and system 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.

 

 

All chairs were occupied when Dr. Ludwig Huber presented the seminar agenda at 9.15 a.m. in the Leela Grand Ball Room

Selected photos with annotations 

The Leela Mumbai Hotel  provided excellent  conference facilities and  environment  for the event.
  The Globalcompliance Panel staff was well prepared to register the attendees and to facilitate the lively discussions between the audience and the presenter.  
  30 minutes before the start of the seminar attendees lined up for registration 
The handout welcome packages have been prepared
  Every delegate received his/her own package 
Attendees especially appreciated the 150+ pages ring binder with copies of the slides and fill-in templates for the workshop exercises.
Here two students are using the workbooks for the exercises.
The conference room was well prepared
  The program agenda was displayed on a huge board in the reception hall.

With this convenience delegates never missed the sessions 
Before the seminars Dr. Huber did go around to many tables to welcome delegates
All delegates were in the conference hall in time not to miss anything.
The technicians were prepared to manage the video and audio equipment for clear sound and video broadcasting
Dr Ludwig Huber explained the agenda, the interactive format and the free reference material.
Each of the 8 modules ended with a Q&A session. They lasted between 15 minutes and 30 minutes.
Attendees used the coffee break to talk to Ludwig Huber
General discussions have been quite interactive and lively
Delegates could enjoy excellent food and drinks during morning, lunch and afternoon breaks
  Delegates also used the break to share their experience with computer system validation and Part 11 compliance. 
  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. 
  During the interactive discussion sessions the delegates had many questions, mainly related to computer validation and data integrity issues. All have been answered by Ludwig Huber
  Also long after official program was finished delegates still had  many detailed and very specific  questions.
Dr Huber answered them all.
  Also on the second day Dr. Huber was always close to the audience, facilitating the interactive format.  
  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?
   
Certificates of Attendance have been prepared for all attendees.
And all of them have been signed with handwritten signatures by Ludwig Huber
It was a challenge to always find the right certificate for the right attendee
Three happy men proudly showing the certificate signed by Dr.Huber
For the general photo session the audience has been divided into two groups.
This shows group one.
Selfies with Dr. Huber have been very popular.
Ludwig Huber with the Global CompliancePanel staff.
The seven staff members ensured a smooth and timely flow of the entire event and facilitated discussions between Dr. Huber and the attendees.
I would like to thank
Global- CompliancePanel for inviting me to present this workshop and for superb organization,
I also thank all attendees for great discussions
Ludwig Huber
ludwig_huber@labcompliance.com  

Other Photos

 

Testimonials

All the testimonials have been received through the feedback forms to Labcompliance seminars, Compliance packages. and SOPs The authors agreed to publish them. Information on the submitters of the testimonials can be reviewed in the Labcompliance archive.

 

Feedback for the 2-Day seminar:
Validation and Part 11 Compliance
of Computer Systems and Data

  1. Feedback from Ms. Divya Krishnakumar, ACG Associated Capsules Pvt. Ltd, Sr. Executive, Central Quality Assurance Department,. India
    The seminar was thoroughly informative and it was explained beautifully such that despite being from a non-IT background, I could understand the topic well enough. The seminar covered important topics and I especially liked the way in which the compliance topics were explained using examples of FDA warning letters .The seminar was very well conducted and was on-time. There were no unnecessary delays.  (Ref T-2124)
  2. Feedback from :Mr. Shibin Chulliparambil, Cipla Limited, Head IT, India
    The seminar did exceed my expectations.
    The seminar gave me insight right from the basic concepts to the advance level which will help in correcting / directing initiatives to achieve compliance . Dr.Huber is definitly a Super Subject matter expert and he communicates the topics very effectively . (Ref T-2126).
  3. Feedback:from  Dr.. Bhavil Kumar Norola, Sun Pharma, Senior Manager Technical Training Academy, India  
    The seminar was excellent. The seminar did exceed my expectations. Information is as per current regulatory guidance and included data integrity and Part 11 very well. .
    (Ref T-2137).
  4. Feedback from Mr. Santosh Pawaskar, Emerson, Manager, PSS Department, India
    The seminar was a great learning for me in 2 days and it has cleared many questions I had about overall validation and about about 21CFRPART11 and data integrity.  The step by step approach helped to understand the validation process. (Ref T-2134).
  5. Feedback:from  Mr. Koushik Rajaram, Aris Pharma, Head Quality, Quality Department, India
     The seminar did exceed my expectation. All areas were covered although briefly but nicely. The presentation was excellent and also the presenter's good interaction with all participants.(Ref T-213
    3).
  6. Feedback from Mr.Himanshu Shekhar, Pathak,  Astrazeneca Pharma, Validation Lead, Technical services Department India:
    The seminar was excellent and it did exceed my expectations, It was very useful and I got all my quires clarified,  (Ref T-2131).
  7. Feedback from  Mr.Sridhar Kulkarni, Dr. Reddy's Laboratories, Manager, QA Department, India
     
    The seminar did exceed my expectations, It was a great one to start with definitive examples. It was was worth the time spent and the knowledge gained. The seminar had practical examples on how to manage a computer system in a regulated environment with definitive answers to critical systems management.(Ref T-2130).
  8. Feedback from Mr. Ulhas Nadekar, Sciformix Technologies Pvt.Ltd, Quality manager, Pharmacovigilance department, India
    The seminar did exceed my expectations. It was helpful as I got to know what are regulatory requirement for Validation. Dr. Ludwig Huber was extremely knowledgeable and supportive. He replied to all questions even during breaks and after the seminar. (Ref T-2129)
  9. Feedback: from Mr. Ashwini Kulkarni, Emcure Pharmaceuticals Ltd, Senior Executive, Quality Assurance Department, India
    The seminar was very informative and it did meet the expectations. The seminar came with good, informative study material .All queries were sorted out. Thank you Dr. Ludwig Huber.  .(Ref T-2128)
  10. Feedback:from Ms. Neva Sahant,  ACG Associated Capsules Pvt. Ltd, Sr. Executive, Regulatory Affairs Department, india (
    The seminar was very helpful. It helped me to be updated with the regulatory requirements for the industry. I was especially interested in the data integrity topic. Topics covered on e-signatures and audit trails was most of interest.. (Ref T-2123)
  11. Feedback:from  Mr Sanjiv Sharma, Panacea Biotec, AGM, QA Department, india
    The seminar did exceed my expectations.
    It was very informative and  discussion with Dr. Huber were very much interactive. , (Ref T-2122)
  12. Feedback:from Mr. Rahul Jain, Lambda Therapeutic, Assistant General Manage,  BioAnalytical department, India
    The seminar was excellent and it did exceed my expectations. It  included nice and excellent presentations on Computer System Validation. It did clarify all queries related to CSV and also provided important tips for another points like Network qualification, Cloud qualification etc. (Ref T-2121)