GLP Comparison with GMP in Quality System -2017

Overview:
Good Laboratory Practice (GLP) is a quality system which intend for non-

clinical studies and was revised by several bodies. GLP is a unique quality

system in the sense it is intend for non-routine processes and activities.

Why should you Attend:
The authorities often required a GLP declaration and statement for submitted

studies. Come to hear more on the requirements and particularly if you

moving from another quality system like GMP or ISO 17025 to GLP, make the

differences between these quality systems clear and prevent confusing

especially if they are coexist in your site.

Areas Covered in the Session:
The Role and Responsibilities of the Study Director in GLP Studies
The Role and Responsibilities of the Sponsor in the Application of the

Principles of GLP
Terms/Vocabulary
FDA GLP
21CFR 58
EPA GLP

Who Will Benefit:
Study Directors
Laboratory Managers
R&D Researchers of Pharmaceutical and Veterinary Companies
Quality Control Staff
Regulatory Affairs (RA) Staff

Speaker Profile:
Eyal Lerner is owner of ELC Consulting Services which offers the

pharmaceutical and medical devices industries support in all quality related

issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-

inspection (internal audits), compliance gap analysis, 3rd party audits (FDF

and API's), Management Review, GMP, GLP,MD: ISO 13485:2016

adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025

(lab accreditation) and Validation.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]