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Workshop: Design Control for Combination Product Development – Fundamentals, Requirements, Practice

June 6 @ 8:00 am - 5:00 pm

Location: Toronto, Canada

A one day intensive interactive presentations, workshop and discussions

Time: 9AM-5PM 

  1. Introduction
    • My background and experience
    • Why design control
    • Purpose of design control
    • Benefits of design control
    • Overview of design control
  2. Scope and Responsibilities
    • Devices requiring design control
    • Scope and responsibility definitions
    • Management responsibilities
  3. Design and Development Planning
    • When a plan is required
    • Elements of a plan
    • Project management
    • Planning tools
    • Change of plans
  4. Design Input
    • Design input definitions and requirements
    • When research ends and development begins
    • Concept vs. design input
    • Sources of design input
    • Inadequate design input
    • Types of design input
    • Document controls
  5. Design Output
    • Design output definitions and requirements
    • Examples of design outputs and specifications
    • Relationship between design output and the product’s Device Master Record (DMR)
  6. Design Reviews
    • Relationship of design reviews to design control
    • Purpose of design reviews
    • Quality system requirements of design reviews
    • Design review board
    • Number and types of design reviews
    • Design review documentation
    • Conducting design reviews
  7. Design Verification
    • Relationship of design input, design output and design verification
    • Design verification definitions and requirements
    • Verification activities
    • Design validation documentation
    • Trace matrix
  8. Design Validation
    • Design verification vs. design validation
    • Design validation definitions
    • Design validation requirements
    • Design validation documentation
    • Clinical trials vs. clinical evaluation
    • Design validation and planning
  9. Test Method, Process, and Software Validation
    • Why validate test methods, manufacturing processes, or software?
    • Relationship between test method, process and software validation to design control
    • Relationship between process and test method validation
    • When to validate test methods and processes
    • Software validation
  10. Risk Management
    • Risk analysis requirements
    • Risk analysis terms and definitions
    • Risk management and activities
    • Risk management tools
  11. Design Changes
    • Design Change requirements
    • Application of design changes
    • Change control objectives
  12. Design Transfer and Process Validation
    • Design transfer requirements
    • Changes during design transfer
    • Relationship of design transfer and validation
    • Process validation requirements
    • Process validation definitions and requirements for:
      • Equipment
      • Process
      • Product performance
  13. Design History File
    1. Design History file definition and requirements
    2. Purpose
    3. Structure
  14. Final Comments and Questions

 

Alan Golden, Principal, Design Quality Consultants, LLC

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

This unique one-day workshop is for professionals in the pharmaceutical, biopharmaceutical and life science industries companies developing a combination product with responsibilities in the following areas:

  • R&D
  • Quality Assurance
  • Regulatory Affairs
  • Production
  • Technical Support

Registration Fee & Discounts:

Early Bird: Till May 08, 2019

Regular Price: May 09, 2019 to June 06, 2019

$528 CAD + HST $628 CAD + HST

 

Academia / Government

At all time 

$388 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.


Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue 

AAPS
2960 Drew Road, Unit 140,
Mississauga L4T 0A5
Canada

Nearby Hotel Accommodation: 

Hilton Garden Inn Toronto/Brampton
2648 Steeles Avenue East, Brampton, Ontario, L6S6J9, Canada
TEL: +1-905-595-5151
Website: https://hiltongardeninn3.hilton.com
Driven Distance: 6 Mins

Four Points by Sheraton Toronto Airport
6257 Airport Road, Mississauga, Ontario L4V 1E4, Canada
Tel: 1 905-678-1400
Website: fourpoints.com/torontoairport
Driven Distance: 12 Mins

 

 

 

Details

Date:
June 6
Time:
8:00 am - 5:00 pm
Event Category:
Event Tags:
, ,

Venue

Toronto, Canada