Establishing Latest Quality Systems in medical device and pharmaceutical industries

[Adam Fleming]

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.

The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as part of a manufacturer’s Quality Management System.

ISO 13485 primarily identifies and traces cleanliness in the area of work environment and helps to manage risks. Although it does not require alignment with 21 CFR Part 820 and other FDA QSR regulations; the two complement each other.

Flexibility individualizes Quality Systems

Despite the assignment of specific tasks from each of these standards for establishing Quality Systems; there is an element of flexibility, because what precisely determines a Quality System varies from one firm to another, based on its values, mission and culture. In these cases, what medical device and pharmaceutical companies are required to do is to define and frame their own Quality Systems and then link them back to appropriate FDA definitions.

This is of critical importance, because when an individual Quality System is framed uniquely for an organization and is not aligned to the respective FDA definition; it makes the company’s regulatory inspections preparedness difficult and laden with impediments. This is one of the fundamental aspects of compliance with FDA regulations.

Professional learning on implementing the right Quality Systems

How do medical devices or pharmaceutical companies build Quality Systems that are effective and are traceable to relevant FDA regulations? The ways of doing this will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Louis Angelucci, who is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation, will be the speaker at this webinar.

Want to gain complete knowledge of how to build Quality Systems that tie with relevant FDA definitions? Want to make sure that your Quality Systems pass FDA regulatory compliance requirements and do not invite penal actions from the regulatory body? Then, register for this learning session by visiting http://www.compliance4all.com/control/w_product/~product_id=501189?...

An explanation of regulatory requirements

During the course of this webinar, Louis will offer participants a perspective of the expectations of a Quality System as they apply to validation. He will also explain the requirements of regulations for the pharmaceutical and medical device industries.

At this webinar on Quality Systems, which will hugely benefit professionals such as QA specialists, Quality Systems Specialist, Managers and Operators, Louis will cover the following areas:

o  Regulatory expectation regarding Quality Systems

o  How to establish Quality Systems

o  Quality systems fundamental

o  FDA definitions

o  Fitting within the FDA puzzle

o  How to maintain and operate within a quality environment.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Post...

http://qualitymanagementsystem.com/iso-13485-saving-lives-through-q...