In-house Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.
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Compliance Workshop 102

Comply with Part 11 - Now and the Future

Put Part 11 in practice through real world examples and case studies

Course objectives

• Understand the spirit and current and future requirements of FDA's 21 CFR Part 11
• Learn about FDA's inspection and enforcement practices for electronic records
• Learn how to define system specific Part 11 requirements based on risk and predicate rule requirements
• Learn how to perform a gap analysis between Part 11 requirements and existing systems and procedures
• Learn how to effectively implement Part 11 in your organization
• Learn how to justify and document your approach for Part 11
• Understand the spirit and current and future requirements of FDA's 21 CFR Part 11
• Learn about FDA's inspection and enforcement practices for electronic records
• Learn how to define system specific Part 11 requirements based on risk and predicate rule requirements
• Learn how to perform a gap analysis between Part 11 requirements and existing systems and procedures
• Learn how to effectively implement Part 11 in your organization
• Learn how to justify and document your approach for Part 11

Contents Overview

• Original intent and history of Part 11
• Part 11 and requirements - Overview and details
• FDA's current inspection and enforcement practices: a risk based approach
• Recommendations from industry task forces, e.g., GAMP
• FDA's new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
• The future of Part 11
• Existing requirements that will go away
• New requirements of the 'NEW' Part11
• Recommended changes to existing Part 11 programs to reduce costs
• Strategy for cost-effective implementation of the 'new' Part 11:
  A six step plan
• Justification and documentation for the FDA and your management
• Case studies from laboratories, offices and manufacturing

Detailed Agenda

Overview of 21 CFR Part 11

• The original intent of Part 11
• Part 11 history, current status and future
• Other regulations: SOX and HIPAA
• FDA's inspection and enforcement practices: Early and recent FDA 483's and Warning Letters
• International regulations and guidelines: EU GMPs, Annex 11, PIC/S
• Recommendations from the industry, e.g., GAMP

Part 11 Requirements

• Validation
• Limited and authorized access
• Accurate and complete copies
• Archiving and ready retrieval
• Electronic audit trail
• Electronic signatures for closed systems
• Digital signatures for open systems
• Authority and device checks

FDA's New Approach: Now and in the Future

• FDA's New Guidance on scope and applications
• FDA's guidance on using computers in clinical trials
• Recent FDA presentations and personal discussions
• FDA's upcoming concern on data integrity
• Focus on predicate rules and risk assessment
• Changes for the 'New' Part 11

Six steps for risk based implementing the new scope

 

Looking at selected requirements

• Alternatives to demonstrate data integrity
  e.g., audit trail, hash sums
• Options to demonstrate authenticity e.g., user ID/PW, biometrics, electronic/digital signatures
• Options to demonstrate confidentiality
  e.g., for closed systems, for open systems
• Options to ensure records availability
  e.g., on paper, standard electronic files, original electronic records
  

Gap Analysis and Implementation Plan

• Document Part 11 controls
• Develop Part 11 requirement specifications
• Define procedural controls, e.g., training
• Developing a gap analysis
• Developing an implementation plan

Documentation for the FDA

• Documentation requirements: system overview, business practices, Part 11 requirements, justification
• Concepts and examples for detailed and summary documentation
• Going through a Part 11 Gap Analysis
• Letter to the FDA to certify electronic signatures
• Employee accountability statement
• Part 11 compliance master plan
• Part 11 compliance project plan
  

Collaborative Exercises, Discussions and Examples

Practical examples, case studies and collaborative exercises 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. Practical sessions include:

• From a large selection of computer systems, attendees will systematically determine which ones should should comply with the new scope of Part 11. Decision will be based on predicate rule requirements, and justified and documented
• Develop steps to demonstrate and document records integrity for two examples
• Using well prepared templates and examples attendees will determine their own examples for detailed and summary documentation. The templates and examples are available in electronic form and can easily customized for other applications
• Going through a Part 11 Compliance master plan
• Attendees will be presented several FDA GLP Warning letters. Attendees will suggest responses and preventive and corrective actions.
  

10+ Reference documents for easy Implementation

The documents can be downloaded from a dedicated seminar website.
They include

• Part 11 Compliance Master Plan
  - Ideal to develop or update your company's Part 11 program\
• Part 11 Primer
  - Training tool for Part 11
• SOPs
  - Define and Document Scope and Controls for Part 11
  - Risk Assessment for Systems Used in GxP Environments
  - Training for GxP and Part 11
  - Retention and Archiving of Electronic Records
  - Recording of GLP Raw Data
  - Validation of commercial of the shelf computer system
• Gap analysis/checklists
  - 21 CFR Part 11
• Templates/examples
  - 10 Part 11 Case Studies
  - Requirement Specifications for Part 11
  - Most frequently asked questions and answers
• Reference papers
  - Data migration and long term archiving for ready retrieval
  - Part 11 in Practice
• FDA Presentation about Part11
  George Smith, FDA: Part 11 - Where we were, Where we are, Where we're going.
• Warning letters and Inspectional observations related to 21 CFR Part11FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend

• Everybody dealing with electronic records used in FDA and other regulated industries
• IT/IS Managers and administrators
• QA managers and personnel
• Quality control managers and staff
• Analysts and lab managers
• Validation specialists
• Software developers
• Members of change control boards
• Regulatory affairs
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants

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 Equipment
• Presenter of the Year of the Institute for Validation and Technology
  Director and chief editor of www.labcompliance.com, 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.