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:
The need for a reliable test equipment which is in a good condition and suitable for its use, is a self-explanatory furthermore when it’s a measuring instrument. “Our results are good as our equipment”. A long with the GMP requirements for validated equipment there are specific requirements and guidelines developed for analytical equipment which revised and updated in USP chapter and chapter . Understanding requirements is essential in order to form appropriate qualification master plan and implant an effective resource management.
Why should you Attend: Unqualified analytical equipment may jeopardize lab results and reliability and damage its reputation. If you part of the quality control (QC) department personal or validation team or quality management, you should attend this webinar. Learn more about analytical instrument qualification: what is expected, how it should be done and latest requirements. For efficient performances and improve communication with the professional staff.
Areas Covered in the Session:
– General Introduction
– Validation, Qualification – Definitions, are they the same?
– Analytical Instrument Qualification- component of Laboratory Data Quality (quality pyramid)
– Regulatory Requirements for Instruments Control
– Regulations, Standards, Guidelines and Procedures
– Terminology and Definitions
– FDA Requirements
– European Union, EMA Requirements
– Analytical Instrument Qualification per USP General Chapter
– Equipment Classification
– Primary steps- URS/DQ
– IQ / OQ / PQ
– Examples
– Software Combined Equipment
– Qualification follow EMA
– EU GMP Guide – Annex 15
– PIC/S document PI 006-2
– Enlightening
– On Calibration and on Analytical Balance in Specific
– Qualification of HPLC
Who Will Benefit:
– Laboratory Employee – All Levels
– QC Managers
– Management which are in liaison with QC and need Better Understanding
– Quality Unit Person which Overview QC
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.
