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How to Validate Equipment According to
FDA Standards
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Michael has over 25 years of experience in
the field of pharmaceutical scale-up, instrumentation
and process optimization. Successfully owned and
operated an instrumentation company. Was teaching
various courses and seminars on wet granulation and
tabulating. Has edited a "Pharmaceutical Process Scale-
Up" book, and has contributed chapters on "Tablet Press
Instrumentation" and "Wet Granulation: End-Point
Determination and Scale-Up" in the Encyclopaedia of
Pharmaceutical Technology. Ph.D. in Biomathematics
(1980) from University of Washington in Seattle. Post
Doctorate at University of Houston, Department of
Mechanical Engineering.
Description
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
This webinar is mainly focus
on Formulators, Process engineers,
Validation, Regulatory compliance and
quality assurance personnel, as well as
production managers who want to ensure
that their equipment and processes are in
compliance with validation requirements of
various regulatory bodies and directives
Why Should Attend
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
This webinar will provide
an excellent insight into the practical
aspects of the Process Validation and
equipment qualification which will be
an invaluable source of information
related to regulatory activity.
Objectives
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
 Qualification vs. validation vs. verification
 Regulations for Process Validation
 Acceptance criteria of equipment qualification
Process Validation
 Validation Protocol as per FDA standards
Who can Benefit
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
 International business operations
 Customs or Trade Compliance
Personnel or Officers
 Export or Global Trade Directors or
Managers
How this Webinar Works
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
 Username and Password will be sent to you 24 hours prior to the webinar
 Presentation handouts in pdf format will be mailed to you
 Login to the session using the username and password provided to you
 Get answer to your queries through interactive Q&A sessions via chat
Track this link
Pharmaceutical Validation
Connect with Us
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Online Compliance Panel

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Equipment Validation-FDA Standards

  • 1. How to Validate Equipment According to FDA Standards www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 2. Instructor Profile www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com Michael has over 25 years of experience in the field of pharmaceutical scale-up, instrumentation and process optimization. Successfully owned and operated an instrumentation company. Was teaching various courses and seminars on wet granulation and tabulating. Has edited a "Pharmaceutical Process Scale- Up" book, and has contributed chapters on "Tablet Press Instrumentation" and "Wet Granulation: End-Point Determination and Scale-Up" in the Encyclopaedia of Pharmaceutical Technology. Ph.D. in Biomathematics (1980) from University of Washington in Seattle. Post Doctorate at University of Houston, Department of Mechanical Engineering.
  • 3. Description www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com This webinar is mainly focus on Formulators, Process engineers, Validation, Regulatory compliance and quality assurance personnel, as well as production managers who want to ensure that their equipment and processes are in compliance with validation requirements of various regulatory bodies and directives
  • 4. Why Should Attend www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com This webinar will provide an excellent insight into the practical aspects of the Process Validation and equipment qualification which will be an invaluable source of information related to regulatory activity.
  • 5. Objectives www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com  Qualification vs. validation vs. verification  Regulations for Process Validation  Acceptance criteria of equipment qualification Process Validation  Validation Protocol as per FDA standards
  • 6. Who can Benefit www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com  International business operations  Customs or Trade Compliance Personnel or Officers  Export or Global Trade Directors or Managers
  • 7. How this Webinar Works www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com  Username and Password will be sent to you 24 hours prior to the webinar  Presentation handouts in pdf format will be mailed to you  Login to the session using the username and password provided to you  Get answer to your queries through interactive Q&A sessions via chat Track this link Pharmaceutical Validation
  • 8. Connect with Us www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com Online Compliance Panel