Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Eyal Lerner
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. Sometime people confuse to see any works which is performed in a laboratory as done or should made in accordance with GLP. For instance, laboratory tests in a pharmaceutical plant however this kind of work are part of the GMP quality system of the pharmaceutical product and not a GLP (even it is done in the laboratory).
GLP is commonly in use in many areas and expended over various fields. It is usually required by regulatory authorities that studies submitted for approval in order to move for next phase (an IND application, for instance) were done under GLP. Obviously new chemicals should be tested for their environmental effects before been approved however it’s also true for long time approved used materials. As science progress and our abilities to explore and identify environmental effects are constantly improved, there is a continuous need to reevaluate these effects in the “old materials”. Effects that were not evaluated at first for a various reasons. These kind of studies are done under GLP. This webinar is introductory to GLP in accordance with OECD, EPA and FDA. It explain what GLP is about, where it should be implemented (and where not), the requirements and comparison to other laboratory quality system like ISO 17025 and GMP.
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:
– Brief Introduction
– GLP, GMP and ISO 17025
– OECD GLP
– Principals
– Test Facility Organization and Personnel
– Quality Assurance Program
– Facilities
– Apparatus, Material, and Reagents
– Test Systems
– Test and Reference Items
– Standard Operating Procedures
– Performance of the Study
– Reporting of Study Results
– Storage and Retention of Records and Materials
– 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
– 40CFR160 & 40CFR792
– Comparison between GLP and GMP
– Summary
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. Eyal worked for the Israel National Accreditation Authority (ISRAC) as head of accreditation of chemistry and Biology and later on as audits director in Teva pharmaceuticals global quality unit. Eyal preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.
