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Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.

Compliance Workshop 102

Validation and Part 11/Annex11 Compliance of Computer Systems and Data

Duration: 2 days

Time: 9.00 am to 5.00 p.m.

Fee: US$ 1499


Flexible in-house or public seminars

Interested in organizing any in-house or public seminar: at any time, anywhere?

If so, click here

Course objectives

Attendees will:

  1. Get an in depths understanding about computer system validation understanding and electronic records & signatures according to FDA, EU and PIC/S requirements
  2. Understand the principles and practices of computer system validation according to GAMP
  3. 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 such as EU and PIC/S
  4. 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.
  5. Learn from Dr. Ludwig Huber's over 25 years industry experience in regulatory FDA and international compliance

Course Outline Day 1

Part 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

Part 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

Part 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 5
  • 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

Part 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 and SOP
  • Disaster recovery plan and SOP
  • Reduce validation costs by using easy to understand and use fill-in blank validation documents
  • Going through examples and fill-in templates

Part 5

Understanding the spirit and basics of the FDA Part 11 and the EU/PICS 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's new 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
  • Preparing for FDA's new inspection and enforcement program
  • 15 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

Part 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

Part 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

Part 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

The Concept of the Interactive Workshops

  • During the workshop practical examples, case studies and collaborative exercises from laboratories, office applications and manufacturing will be dispersed into and between the presentations. At least 50% will be dedicated to practical sessions with life examples. The outcome will be made available for all attendees on a special workshop reference website.
  • After the workshop attendees will have access to 30+ best practice guides such as instrument qualification and computer validation templates, examples, checklists and SOPs. This will enable attendees to easily implement what they have learned 

Who will benefit from the course

By function

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Users of computer systems used in regulated areas
  •  Validation specialists
  •  Software developers
  •  Regulatory affairs
  •  Training departments
  •  Documentation departments
  •  Consultants

By industry and organizations

  • Pharmaceutical development and manufacturing
  • Biopharmaceutical development and manufacturing
  • API manufacturing
  • Medical device development and manufacturing
  • Clinical research organizations
  • Contract laboratories
  • Equipment suppliers and service providers supporting related organizations
  • Consulting firms

What attendees get

  •  Workshop conducted by an internationally recognized compliance expert
  • Industry proven real-life case studies
  • Highly efficient workshop exercises through prefilled templates
  •  Answers to any issues directly by the trainer in an one-on-one interaction
  • Take home SOPs, templates and examples for cost effective implementation
  • Access to the PowerPoint presentations to train others in your company
  • 30 days phone and e-mail post workshop support through the trainer
  • Certificate of training completion
  • Detailed documentation of the trainer's qualification

More info?

If you are interested in this In-house workshop or in organizing it as public workshop, please click here.

About the speaker: Dr. Ludwig Huber

  • 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 Systems
  • Presenter of the Year of the Institute for Validation and Technology, selected out of 170 speakers
  • Director and chief editor of, the global on-line resource for validation and compliance issues.
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • For more information on Ludwig Huber, click here.
Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Free best practice guides for Computer Validation

  • SOP: Validation of Laboratory Computer Systems
  • SOP: Periodic Evaluation and Review of Computerized Systems
  • SOP: Revalidation of Software and Computer Systems
  • SOP: Risk Based Qualification of Network Infrastructure
  • SOP: Auditing Computer Systems
  • SOP: Validation of Spreadsheet Applications
  • SOP: Development und use of Spreadsheet Applications
  • Gap analysis: Laboratory computers systems
  • Template/Examples CDS Validation from Beginning to the End - Step-by-Step
  • Template/Examples CDS Project plan
  • Template/Examples CDS Requirement specifications
  • Template/Examples CDS Vendor qualification
  •  Template/Examples CDS Installation qualification
  • Template/Examples CDS Operational qualification
  • Template/Examples CDS Performance qualification
  • Template/Examples CDS Test plan
  • Template/Examples CDS Validation report

Free best practice guides for Part 11/Annex 11

  • SOP: Integrity and Security of Electronic Data
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • SOP: Define Scope and Controls for Part 11
  • Case Studies: Part 11 Implementation
  • Checklist: Security and Integrity of Electronic Data in Laboratories
  • Checklist: Electronic Audit Trail
  • 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
  • Retention and Archiving of Electronic Records
  • Checklist: FDA Record Retention and Retrieval
  • Regulatory reference document:
    Drug cGMP Requirements for Laboratory Records
  • Regulatory reference document:
    FDA GCP Regulations: Requirements for Clinical Trial Records
  • FDA Presentation: Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?
  • FDA Presentation:  Steve Wilson FDA Regulatory Perspective an Data integrity
  • Warning letters and Inspectional observations related to laboratory data integrity and security
  • Literature Reference Papers.
    - Implementing 21 CFR Part 11 - Data Migration and Long Term Archiving for Ready Retrieval
  • Warning letters and Inspectional observations related to electronic raw data and other electronic records.
  • FDA guidance documents and predicate rules

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