Moving from the GMPs to the Pharmaceutical Quality System

  • Speaker:John Lanese
  • Duration:90Min
  • Product Code:GRC-90372

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Certification:
GRCTS Completion Certificate.

Topic Background:

Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System.  This is supported by an FDA Guidance Document: Guidance for Industry  Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System.  It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10; The Pharmaceutical Quality System.  In this audio seminar we will discuss the systems that a firm must implement to be compliant with the CGMPs which is actually an implementation of the Pharmaceutical Quality System.

This live webinar will cover:

  • The migration to Quality Systems
  • ICH Q8, ICH Q9, ICH Q10, the Quality Metrics Guidance and the Process Validation guidance
  • The interrelationship of the Quality System related guidance
  • Implementation of the Quality System concepts into programs that support a contemporary interpretation of the GMPs
  • The impact of Quality Metrics

Learning Objectives:

  • ICH Q10; The Pharmaceutical Quality System and how it impacts compliance to the CGMPs?
  • The elements of ICH Q10 and how they relate to the GMPs.
  • The ICH Q10 enablers and the challenge of Knowledge Management
  • The impact of ICH Q8; Pharmaceutical Development, ICH Q9; Quality Risk Management and the 2011 FDA Guidance on Process Validation
  • Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
  • The use of the lifecycle concept in FDA guidance including the Process Validation Guidance and a USP stimuli article

Who should attend:

  • Senior management – CEO, VPs
  • Middle management - Directors, Managers
  • Quality personnel – all levels
  • Operations personnel – all levels

Speaker:

John G. (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.  Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics.  He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. 

Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, “GXP Talk” in the Journal of GXP Compliance.

Available Options

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,649

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,659

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