ISO Regulations for Medical Devices

Live Webinar
Date: Wednesday November 28, 2018
Time: 11:00 AM ET | 8:00 AM PT
Duration: 90 Mins with Q&A

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This webinar will describe general difference and similarity between GMP and ISO. We will see the revision history of ISO 9001 and ISO 13485. We will discuss the new 2016 Revision of ISO 13485 which will be in effect on March 1st, 2019

Why Should You Attend:

Learn ISO approach to a general quality, its similarity and difference with GMP approach. Understand ISO 9001 and ISO 13485 and to learn the new 2016 Revision of ISO 13485. This seminar will help you to be ready for the new Revision of ISO13485 by offering you a comparison between current and new revision of the standard.
After this seminar you will be able to perform GAP analysis of your current system and be ready for the new standard revision.

Areas Covered in the Webinar:

  • ISO Meaning
  • Quality management systems
  • ISO 9001 Quality Standards
  • ISO 13485 Medical Devices
  • Revisions History of ISO 9001 and ISO 13485
  • What’s New and How to be Ready for ISO 13485: 2016

Natasha Demberg, President, Demberg PharmaSolutions

Natasha Demberg is a Pharmaceutical and Biotechnology Quality and BD Executive with 25+ years in the development and application of Quality Management Systems throughout the product life-cycle (development, scale-up, and commercialization) and Business Development for Pharmaceutical service providers. She created and managed Quality Organizations, which operate under different cGMP regulations such as: Pharmaceutical, Pharmaceutical Class IV (OTC), Medical Devices class IV – I, Natural Health, and Cosmetic Act as well as ISO 9001 and ISO 13485 regulations.

Mrs. Demberg is experienced in leading multi-functional groups to address challenging global regulatory compliance issues, develop strategy for Quality and Business Development, and create company culture oriented to Quality and Customer needs. Mrs. Demberg has audit expertise that spans cGMP compliance, mock-FDA and HC inspections, PAI readiness, and suppliers and vendors audits and qualification. As a BD executive Mrs. Demberg has an expertise of creating the client oriented company culture, efficient customer support and service, and Business Development and sales.

Currently, Mrs. Demberg is providing Quality & Compliance, consulting services for Pharmaceutical and Biotechnology firms. In addition to Quality & Compliance, Mrs. Demberg provides Business Development support to the service companies in Life Science industry.

She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.

Natasha’s career has included a wide range of successful leadership positions in Quality Organizations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations, and Vice President Pharmaceutical Solution at Neopharm Labs.

Mrs. Demberg holds a BSc in Chemical Engineering and a MSc in Chemistry of Polymers and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.

Target Industry:

Pharma & Biotech

Who Will Benefit:

Personnel involved in any stage of product lifecycle: design and development, production, storage and distribution, installation, servicing, final decommissioning and disposal of medical devices and design. Personnel involved in Quality Systems management (ISO and GMP) and Quality Assurance activities such as product release, recall, Regulatory Body Inspection and Registrar inspection handling.

Registration Fee:

Register Today!

Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.

Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at for any other enquiries.