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