In-house Compliance Workshop

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Compliance Workshop 103

Good Laboratory Practices

Introduction, Requirements and Tools for Implementation

Course objectives

• Get a thorough understanding of FDA and international GLP regulations
• Learn how to effectively implement GLPs in their groups and departments
• Understand consequences of non-compliance

Contents Overview

• FDA and International GLP regulations: 21 CFR Part 58
• Objectives and concepts of GLP's
• Special organizational requirements
• Responsibilities: Management, Study director, QA, analysts
• SOP requirements: type, formats and enforcement
• GLP studies: preparation, conduct, documentation
• Key requirements for equipment, facilities reference material, people
• Data generation and evaluation: raw data, intermediate results, final results
• Records keeping: format, length of time, archiving and reprocessing
• Preparing for FDA inspections
• Real life examples

Detailed Agenda

FDA and International GLP Regulations

• FDA 21 CFR 58: history, objectives, scope
• OECD GLP principles
• Who has to comply with which regulation
• GLP vs. GMP and Good Clinical Practices
• Inspection practices and enforcement
• Key provisions of a GLP study

Organizational requirements

• Organizational structure
• Responsibilities: Management, QAU, study director, staff
• Involvement of personnel in synthesis, analytical laboratories, toxicology, metabolism and related functions
• Policies and mission statements

Requirements for People, Equipment, Facilities, Chemicals

• People qualification: education, experience, training
• Documenting evidence of successful trainings, certification of employees
• Equipment qualification and computer validation
• The validation/qualification lifecycle, steps and documentation
• Facilities: size, access, construction
• Regents and solutions: handling, storage, documentation
  

SOP requirements: type, formats and enforcement

• SOPs related to other documents
• When are SOPs required
• Format of SOPs
• Writing, approval, distribution, obsolescence
• Managing electronic SOPs
• Handling deviations from SOPs
• Workshops and examples

GLP Study

• Study plan: contents, responsibilities, schedule
• Conduct of a study
• Study protocol: contents, level of detail
• Study report: contents and approval, archiving
• Reporting deviations from the plan

Management of raw data and other records

• Definition of raw data
• Acquisition and recording of raw data
• The importance of 21 CFR Part 11 for electronic records
• Maintenance, archiving and retrieval
• Archiving period
• The role and responsibilities of the archivist

Documentation Requirements

• Overview of required documents
• Developing SOPs for equipment qualification and maintenance
• Developing test scripts
• Electronic vs. paper documentation

GLP Inspections and Enforcement

• FDA's GLP inspection program
• FDA's inspections abroad
• The value of FDA's GLP inspection manual
• Inspections in countries with Memorandum of Understanding
• Inspections of sub-contractors
• 'Routine' vs. 'For Cause' inspections
• Disqualification of a testing facility
• Preparing for successful FDA and international inspections

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:

1. Establishing an org. chart for GLP
2. We will go through a GLP audit checklist
3. Attendees will be presented several FDA GLP Warning letters. Attendees will suggest responses and preventive and corrective actions.
4. Development of a training plan
5. Attendees will be presented several FDA GLP Warning letters. Attendees will suggest responses and preventive and corrective actions.
6. Examples: Documents to be developed throughout an equipment qualification lifecycle
7. Workshop: Managing deviations from SOPs
8. Case studies: going through five example SOPs
9. Workshop: For a given example, attendees will write a table of contents and keywords for a study report
10. Definition of raw data for combined electronic/paper based systems
11. Workshop: List of validation tasks and associated deliverables along the equipment life. What needs to be done and documented when?
12. Going through an example package for equipment qualification 

10+ Reference Documents for Easy Implementation

• The documents can be downloaded from a dedicated seminar website.
• They include (for examples, see the end of this page)
• Primer: Good Laboratory Practices and Current Good Manufacturing Practices,120 pages
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• Worksheet: Laboratory audits
• SOP: Recording of GLP Raw Data
• SOP: Archiving GLP Data and Other Documents
• SOP: Historical SOP File for GLP Regulations
• SOP: Handling and Reporting of GLP Study Deviations
• SOP: Generation and Maintenance of SOPs
• SOP: Facilities and Environmental Control
• SOP: FDA inspections - Preparation, Conduct, Follow-up
• SOP: Handling Deviations from Standard Operating Procedures
• SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
• SOP: Retention and Archiving of Electronic Records
• SOP for EMEA GLP Inspections
• FDA Warning Letters and inspectional observations related to GLP
  21 CFR Part 58: Good Laboratory Practice for Non-clinical Laboratory Studies
• FDA Compliance Manual for Inspectors: Good Laboratory Practice (Nonclinical Studies)
• Inspection and Verification of Good Laboratory Practices: Annex to EU Council Directive 88320EEC

Who should attend

• Everybody involved in GLP studies
• Lab Supervisors and Managers
• QA managers and personnel
• GLP auditors
• Analysts
• IT managers and personnel
• Regulatory submission groups
• Documentation department
• Training departments
• Consultants
• Teachers

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.