ComplianceOnline

Critical Parameters and Design, Process and Purchasing Controls

Instructor: Vinny Sastri
Product ID: 700392
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Design control training will highlight importance and methods of identifying critical parameters during design and controlling them during production to ensure the safety and efficacy of the device.

Description

The FDA 21 CFR Parts 820 Quality Systems Regulations requires that quality is designed into the product to ensure the production of safe and effective devices for the intended use.

Thus it is important to identify the critical parameters that will affect the key properties of a finished device. Once these critical parameters or components have been identified, they should be controlled all the way from receiving, during manufacturing and assembly, and, in the finished device. Identifying the critical components should occur during product design (Design Controls). Component quality and consistency should be tested and evaluated from the suppliers (Purchasing Controls) and during production (Production and Process controls). This Webinar will highlight importance and methods of identifying critical parameters during design and controlling them during production to ensure the safety and efficacy of the device.

Areas Covered in the seminar:

  • Overview of FDA 21 CFR Parts 820 and Design, Process and Purchasing Controls
  • Identifying critical parameters
  • Critical parameters and specifications
  • Controlling critical parameters
  • Critical parameters and Design Controls
  • Critical parameters and Process Controls
  • Critical parameters and Purchasing Controls

Who Will Benefit:

This webinar will be of value to those who want to understand how to identify and control the critical parameters that affect the safety and efficay of a device. Functions that will benefit from this webinar include:

  • Technical managers
  • Product development teams
  • Quality engineers
  • Quality managers
  • Manufacturing engineers and managers
  • Purchasing managers

Instructor Profile:

Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.

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