Medical devices being a global market; it is not surprising to see many medical device companies marketing their products in both the US and the European Union (EU), two huge markets for these products. Given that these are two different markets; each has its own regulatory requirements. These requirements focus mainly on its Quality Management Systems (QMS). The QMS for the two markets are described in two documents: one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR 820).
On the surface, these two systems appear similar as they have many features in common. But as one delves a little into them, it turns out that they are not identical. A regulatory professional who markets medical devices into these two markets is likely to face crucial questions:
· Is it possible, and is it permitted to have a QMS on the same site that complies with both requirements?
· Should one QMS comply with both, and should that be put in place, or is it necessary to have two QMS coexist on the same site?
Thorough learning of the ISO and FDA QMS requirements
Answering questions such as these requires a thorough understanding of the background of both these documents, their legal status, what is expected by the regulatory authorities, and some basic concepts in quality and medical devices quality in specific. This is the learning that a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance, will impart.
At this webinar, Compliance4All brings the owner of ELC Consulting Services, Eyal Lerner, as expert. Eyal’s organization offers the pharmaceutical and medical devices industries support in all quality related issues, such as 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 has preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.
Please visit http://bit.ly/2JDpIWO to enroll for this webinar and have important doubts about the implementation of the QSRs of the ISO 13485 and 21 CFR 820 regulations clarified.
Offering insights into the two regulations
At this webinar, Eyal will give clarity to participants on how to understand what is required by both. It is necessary for regulatory professionals to understand semantic and substantial differences between the two documents. To give an example, while the ISO requires what it calls a Quality Manual (QM), the FDA QSR does not find mention of such a term. An in-depth look at the policies and Standard Operating Procedures facilitates the ease of handling of such terms. Eyal will focus on other issues that require more attention. He will explain the main features of these areas and describe what should be done from the perspective of a site or a manufacturer which wants to comply with both QMS.
The objective of this learning session is to offer a clear understanding to organizations in the medical devices industry that either develop or plan to market medical devices to USA and Europe of how to plan and implement a QMS that complies with both regulatory authorities. Eyal will help them ask themselves how to get the QMS right and make it work efficiently.
This session is aimed at professionals who are involved in implementing their organizations’ QMS, and includes Medical Devices Quality Personal (QA and QC), Laboratory Managers, R&D Researchers of Medical Devices and Combined Products, Quality Control Staff, and Regulatory Affairs (RA) Staff.
The speaker at this webinar will cover the following areas:
· Brief review of regulations and standard: status and history
· ISO 13485:2016 short review
- Quality management system
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
· FDA QSR (21CFR820) short review
- Quality System Requirements
- Design Controls
- Document Controls
- Purchasing Controls
- Identification and Traceability
- Production and Process Controls
- Acceptance activities
- Nonconforming Product
- Corrective and Preventive Action
- Labeling and Packaging Control
- Handling, Storage, Distribution, and Installation
- Statistical Techniques
· Comparison between both QMS
- Common features
- Variances between both
· Terms/ vocabulary
- Comparison between terms