Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 229

How to Efficiently  Build a GLP Laboratory

Step-by-step from design to cost-effective implementation

 Recorded

Being able to perform GLP studies expands a laboratory's business opportunities but there are also costs involved.  Performing GLP analysis internally as opposed to outsourcing them to contract laboratories can save time and money, especially for large sample number studies. However, because of regulatory requirements building a GLP laboratory needs to be thoroughly planned, designed and implemented. This holds for planning of organizational and management structure, for facilities and equipment, and for documented staff training. 

Key Questions related to building a GLP laboratory are:

• Who has to comply with GLP regulations?
• What are the differences between FDA and international GLP regulations?
• What are the key differences between a GLP and non-GLP work?
• What are the incremental costs?
• What are the key benefits in-house GLP analysis vs. outsourcing?
• What are the key requirements related to laboratory facilities?
• What are the management and organizational requirements?
• Which type of documents should be developed?
• Do we need any additional people with different qualifications?
• How should we archive GLP data: paper, microfiche, electronic?
• We already have ISO 17025, how to upgrade to GLP?
• We already are GMP certified, how to upgrade to GLP?

How does the audio seminar help:

A good understanding of GLP regulations together with a good strategy for planning, design and implementation not only can keep the costs under control but provides assurance that the lab will pass FDA and other GLP inspections. Answers to the questions above will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and International GLP regulations: 21 CFR Part 58
• Similarity and difference to ISO 17025 and GMP
• Documentation requirements: Policy, master plan, SOPs, records
• Special organizational requirements: study director, QAU, archivist
• Developing a master plan with step-by-step implementation plan
• Developing SOPs. type, formats and enforcement
• GLP studies: preparation, conduct, documentation
• Hiring and management of the right personnel
• Assigning tasks and responsibilities:: Management, study director, QA, analysts
• Designing and/or optimizing the laboratory facilities for GLP Studies
• Brining new and existing equipment and test methods into GLP compliance
• Develop a strategy and a protected archive for electronic records
• Records keeping: format, length of time, archiving and reprocessing
• Upgrading from existing ISO 17025 accreditation and GMP compliance.

And for easy and instant implementation:
download 10+ documents from special seminar website

• Master Plan Template and Examples: Building a GLP Laboratory
• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages primer
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• Worksheet: Laboratory audits
• SOP: Training for GLP Compliance
• SOP: GLP Facilities and Environmental Control
• SOP: Recording of GLP Raw Data
• SOP: Archiving GLP Data and Other Documents
• SOP: Historical SOP File for GLP Regulations
• SOP: Retention and Archiving of Electronic Records
• SOP: Handling and Reporting GLP Study Deviations
• 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)
• And more...

Who should attend?

• Laboratory managers and staff
• Analysts
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department
• Consultants

Date, time and duration

Order at any time, replay at any time.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.