Design Controls Implementation-21 CFR 820.30 Webinar

In 2013, design controls were the #1 cause of FDA 483s. Design controls is 1 of 4 major quality subsystems that FDA will review during a QSIT level II inspection.

Our instructor, Rob Packard of Medical Device Academy, reviews basic concepts and requirements of each design phase of the design process from design plan approval through commercial launch approval, including: 

  • Design planning
  • Design inputs
  • Design outputs
  • Design verification
  • Design validation
  • Design reviews and more.

The Phase Gate Approach-concept and benefits. You will learn how large companies manage product design-related projects (5-6 hard gates) and keep them on schedule.

The lifecycle loop-(Post Market Surveillance, Risk Analysis, and Clinical Evaluation Reports) is illustrated to explain why docs should be updated on a regular basis.

Numerous diagrams are utilized throughout the presentation. One exclusive diagram shows you how to implement risk management throughout the design process.

design control promo graphic Design Controls Implementation 21 CFR 820.30 Webinar

This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

LOGO FINAL11 Design Controls Implementation 21 CFR 820.30 Webinar
Design Controls Implementation-21 CFR 820.30 Webinar

Our instructor, Rob Packard of Medical Device Academy, reviews basic concepts and requirements of each design phase of the design process from design plan approval through commercial launch approval, including:
Design planning
Design inputs
Design outputs
Design verification
Design validation

Price: $129.00

Exam and Training Certificate available for $49.00:

exam11 150x150 Design Controls Implementation 21 CFR 820.30 Webinar
EXAM – Design Controls Implementation-21 CFR 820.30

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

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SOPS Design Controls Implementation 21 CFR 820.30 Webinar

About Your Instructor

Medical Device Academy Robert Packard Design Controls Implementation 21 CFR 820.30 WebinarRobert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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