In-house Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.
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Compliance Workshop 108

Using Electronic Raw Data and Other Electronic Records in Regulated Environments

Definition - Acquisition - e-Signatures - Archival

Course objectives

• Understand regulatory requirements for electronic data
• Understand how to develop a strategy for management of electronics records from definition to archiving and retrieval
• Get and understand the tools to implement the strategy
• Attendees get the tools and knowledge to teach others in the company

Contents Overview

• FDA Requirements for raw data and other electronic records
• FDA Inspection and enforcement practices
• Recommendations from industry task forces: GAMP/ISPE guides
• Definition of raw data: original records vs. standard electronic formats, paper print-outs
  Ensure and demonstrate integrity of raw data
• The importance of risk assessment for the management of raw data
• Ensure data integrity during automated and interactive evaluation
• Strategies for long term archiving: paper, PDF files, original records
• Electronic record maintenance during archiving period
• Software to manage and archive raw data and other electronic records
• Data migration to new systems
• Developing a procedure for consistent raw data management
• Using electronic lab and other notebooks for data recording and sharing
• Converting paper to electronic records: technology and legal issues
• Examples from laboratories, offices and manufacturing

Detailed Agenda

 

FDA and International Requirements and Enforcement

• FDA GPL/GCP and GMP regulations and Part 11
• Examples of FDA 483's and Warning Letters
• European and International regulations and guidelines: EU GMPs, Annex 11, PIC/S
• Industry guides: GAMP and PDA
• Sarbanes Oxley (SOX) and HIPAA
• European Digital Signature Directive
• Requirements for long term archiving: electronic formats vs. paper 

Definition and Handling of Raw Data

• Definition of raw data in the paper world
• Definition of electron raw data
• Recording of raw data
• Ensuring integrity of electronic raw data
• Changing raw data: the importance of electronic audit trail
• Copying of raw data: to other electronic media, to paper
• Requirements for electronic data systems

Handling Electronic and Digital Signatures

• Definition of electronic vs. digital signatures
• Applications of electronic and digital signatures
• Requirements for electronic signatures
• Requirements for digital signatures
• Binding signatures with records
• Tools to execute electronic and digital signatures

Using Electronic Notebooks for Data Recording and Sharing

• Benefits of Electronic Notebooks (ELNs): example Laboratory Notebooks
• Applications of ELNs in different departments
• Selection criteria for specific applications or departments
• Legal requirements for laboratory notebooks
• Writing specifications for ELN
• Implementing Part 11 requirements for existing ELNs
• Preparing an ELN System for an FDA inspection
• Integrating laboratory notebooks with other systems
• The ultimate benefit: Sharing information across departments and sites

Cost Effective Data Archiving

• Issues with electronic archiving
• Options for e-archiving: standard files, proprietary formats
• Storage media for long term archiving
• Record maintenance during the archiving period
• Scanning paper for electronic archiving
• Requirements for electronic archiving systems
• Archiving strategies
• Recommendations for implementation

Collaborative Exercises, Discussions and Examples

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.

Attendees can choose from any of the prepared systems below or use their own

• Chromatography data systems
• Automated Infrared Spectrometer Analysis
• Data Base to Keep Track of and Schedule Preventive Maintenance of Equipment
• Recording Oven Temperature for Stability Testing
• Electronic batch records
• Training tracking system
• Using an Excel Template as a Calculator
• Using a Word Processor for Paper and/or Electronic SOPs
• Paper Scanning for Electronic Archiving
• Clinical Study Reporting over the Public Internet

Tasks of practical sessions include:

• Definition of raw data for various applications
• Developing a list of requirements for electronic systems
• Define how to archive the data
• Define and document archiving procedures
• Summary "to do" list
• Schematic documentation for inspections

10+ Reference Documents for Easy Implementation

This material will help  attendees to quickly implement what they have learned in the seminars

• SOP: Retention and Archiving of Electronic Records
• SOP: Recording of GLP Raw Data
• SOP: Archiving and Retrieval of GMP Data and Other Documents
• SOP: Validation of Electronic Document Management Systems
• SOP: Scanning of Paper Records for Electronic Arichiving
• SOP: 21 CFR Part11 - Scope and Controls
• SOP: Using Electronic Laboratory Notebooks in Regulated Environment
• Checklist: Using Computers in FDA Regulated Environments
• Checklist: FDA Record Retention and Retrieval
• FDA Presentation from March 2007: Data Integrity and Fraud – Another Looming Crisis?
• Regulatory reference documents:
  - FDA Drug cGMP: Requirements for Laboratory Records
  - FDA Drug cGMP: Requirements for Manufacturing Records
• 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

Who should attend

• Lab managers and analysts
• Quality control managers and staff
• Record managers
• Documentation professionals
• QA managers and personnel
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• Training departments
• 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.