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FDA 21 CFR 820 - QSR Session # 3: "Design Control: Using Best Practices a...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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FDA 21 CFR 820 - QSR Session # 3:

"Design Control: Using Best Practices and Avoiding Common Pitfalls "

ASQ NCDG March 2018 Roundtable

Wednesday, March 28, 2018, 7:00 - 9:00 pm

Topic: Design Control (21CFR 820.30 and ISO 13485:2016 Section 7.3)

ASQ NCDG will be discussing Design Control (21CFR820.30 and ISO 13485:2016 Section 7.3) best practices and how to avoid common pitfalls during the design and development of a new product.

Do you have the necessary skills to ensure the effectiveness of a robust Design Control system in your medical device company?

During the presentation, Farhan Shahab will cover the following topics:

  • Mapping out the user needs, design inputs, risk analysis controls and design outputs

  • What is the difference between design verification, design validation and process validation?

  • Best practices in putting together a Design History File

  • # 1 reason for getting 483s or Warning Letters on Design Control

  • Avoiding common pitfalls during the design development process

  • What areas of Design Control have updated in ISO 13485:2016?

We will go through some discussions during this session in order to ensure attendees have a chance to share their experience and learn from others.

Featured Speaker: Farhan Shahab

  • 20 years of Quality and Regulatory experience in the medical device industry

  • BS in Chemical Engineering, minor in Resource Economics and Chemistry

  • MBA (Masters in Business Administration)

  • ASQ CQE (Certified Quality Engineer)

  • ASQ CSSBB (Certified Six Sigma Black Belt)

  • Exemplar Global Certified Associate Auditor

  • RAC-US (Regulatory Affairs Certification, United States)

  • Adjunct Faculty Regulatory Affairs Medical Devices, UC Santa Cruz

Moderator: Anesh Tilwani

Anesh Tilwani is a Senior Quality Engineer at Illumina and active ASQ Biomedical NCDG board member, currently serving as the discussion group's Chair Elect. In the past, Anesh served as the Secretary and Finance Coordinator for ASQ Biomedical NCDG.

Registration Link: NCDGMAR2018.eventbrite.com

Register online early for discount & save.

Only Credit Card accepted at door (via Eventbrite)

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel: gjmarcel@gmail.com

Questions: For information about this session, contact George Marcel: gjmarcel@gmail.com

Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only.

Please limit distribution to attendees: personal professional use only.

For those not in the Northern California / Bay Area, and those locally who cannot attend the session, in person:

Webinar Remote Access (no cost) Option: https://attendee.gotowebinar.com/rt/6376324503535979521

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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