David N. Muchemu
Instructor David N. Muchemu
Product Id 600424
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Bringing Compliance To Design Control For Older Products

Overview:

The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File.

The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the paper trail you are required to maintain to show compliance.

Compliance regulations are released by regulatory bodies throughout the product's life cycle. It is a requirement for the manufacturer of devices to ensure that the released product is in compliance with applicable laws.

Areas Covered in the Session:

  • Design control defined
  • Design validation
  • Design change control
  • Design History File
  • Product life cycle

Who Will Benefit:
  • Quality Personnel
  • Regulatory Affairs
  • Design Engineers
  • Manufacturing Engineers
  • Process Engineers

Speaker Profile
Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.

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