GLP Comparison with GMP in Quality System 2017

GLP Comparison with GMP in Quality System is organized by Compliance4All and would be held on Oct 04, 2017. The target audience for this event for Study Directors, Laboratory Managers, R&D Researchers of Pharmaceutical and Veterinary Companies, Quality Control Staff, Regulatory Affairs (RA) Staff.

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

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.

Additional details will be posted as soon as they are available.