• The OECD Principles of GLP
• 26 min
  1. Good laboratory practice: principles, compliance and mutual recognition, history and OECD framework

  • Dr. Dian Turnheim
• 17 min
  2. Scope and application

  • Mr. David Long
• 19 min
  3. Performing test systems and test items

  • Prof. Sergio Caroli
• 30 min
  4. Why OECD GLP and not ISO / IEC 17025?

  • Dr. Helen Liddy
• 29 min
  5. Principles of GLP

  • Mr. David Long
• 30 min
  6. Performing: standard operating procedures

  • Mrs. Katariina Rautalahti
• 25 min
  7. GLP: planning, recording, and archiving

  • Mr. Phil Withers
• 53 min
  8. Reporting of study results

  • Mr. Hedwig Beernaert
• 16 min
  9. Quality assurance

  • Mr. David Long
• 43 min
  10. Facilities: buildings and equipment

  • Mr. Hedwig Beernaert
• 46 min
  11. Multi-site studies and field studies

  • Dr. Geetha Rajashekhar
• 18 min
  12. In vitro studies and short term studies

  • Prof. Sergio Caroli
• 40 min
  13. Computers in a GLP environment

  • Mr. John McNamee
• 23 min
  14. The application of the GLP principles in analytical chemistry

  • Prof. Sergio Caroli
• 21 min
  15. Good laboratory practice: roles and responsibilities

  • Mr. David Long
• Monitoring GLP Compliance
• 31 min
  16. Monitoring GLP compliance: history and OECD framework

  • Mr. Richard Sigman
• 35 min
  17. Compliance monitoring systems and organization around the world

  • Mr. Theo Helder
• 30 min
  18. Inspection procedures

  • Mr. Theo Helder
• 38 min
  19. OECD guidance for national compliance monitoring programmes: carrying out study audits

  • Ms. Louise Calder
• 24 min
  20. GLP in the European Union

  • Mr. Maik Schmahl
• 42 min
  21. Regulatory requirements in Japan and its compliance monitoring programmes

  • Dr. Hitoshi Someya
• International Data Acceptance Through OECD
• 28 min
  22. International data acceptance through OECD: history and OECD context

  • Mr. Richard Sigman
• 17 min
  23. History and rationale for the development of an international evaluation programme

  • Mr. Theo Helder
• 9 min
  24. Participation of non-OECD economies in the MAD system

  • Ms. Christinah Leballo

Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Outline
3. Principles of GLP - applicability
4. What is GLP?
5. GLP feature - study
6. GLP competence established (1)
7. GLP competence established (2)
8. ISO/IEC 17025 - applicability
9. What is accreditation?
10. Features common to GLP and 17025
11. 17025 competence established (1)
12. 17025 competence established (2)
13. Evaluation of technical validity
14. Legislation and regulation
15. GLP specific requirements
16. Scope of ISO/IEC 17025 and GLP
17. Integrated quality system?
18. OECD position paper (1)
19. OECD position paper (2)
20. Conclusions (1)
21. Conclusions (2)
22. Conclusions (3)
23. References (1)
24. References (2)

Topics Covered

• Principles of GLP v ISO/IEC 17025
• Similarities and differences
• OECD discussion paper
• Implementing a combined GLP/ISO 17025 quality system

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

• Dr. Helen Liddy has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.