Description :
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.
Areas Covered in the Session :
FDA and International GLP regulations: 21 CFR Part 58, OECD
Examples for FDA 483 inspectional observations and warning letters
Objectives, scope 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
Strategies for Multi-site GLP Studies
Preparing for FDA inspections
Who Will Benefit:
Everybody getting involved in GLP studies
Lab Supervisors and managers
QA managers and personnel
GLP auditors
Analysts
Consultants
Teachers
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.
Areas Covered in the Session :
FDA and International GLP regulations: 21 CFR Part 58, OECD
Examples for FDA 483 inspectional observations and warning letters
Objectives, scope 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
Strategies for Multi-site GLP Studies
Preparing for FDA inspections
Who Will Benefit:
Everybody getting involved in GLP studies
Lab Supervisors and managers
QA managers and personnel
GLP auditors
Analysts
Consultants
Teachers
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
