Speaker Profile
Eyal Lerner
Pharmaceutical Quality Consultant, ELC Consultant Services
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.
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details
The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View Details