Process Validation General Principles & Practices - FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

  • Speaker:John Lanese
  • Duration:90Min
  • Product Code:GRC-90409

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • 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.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • 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)

This Training is available for On Site and Corporate Training

Certifications: GRCTS Attendance Certificate

Integrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics”

Description: 

ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle.  Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes.  ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10.  In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices.  This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle.  The Europeans followed with a similar guidance for process validation including the lifecycle concept.  This has now been incorporated into the revised Annex 15: Qualification and Validation of the EU GMPs. Worldwide, the pharmaceutical community is approaching process validation as a process control tool that is applied to pharmaceutical production processes throughout the life of the process and the product.  It is now a challenge for the process validation team to integrate a life-cycle approach into the development and validation of new processes and the verification of the validation of old processes.

Objectives: 

The objective of this webinar is that attendees will better understand contemporary expectations for process validation and how these supports the quality system approach to compliance.

In this webinar we will discuss: 

The FDA Guidance on process validation and how the expectations found in this guidance correlate to:

  • ICH Q10; The Pharmaceutical Quality System
  • ICH Q9; Quality Risk management
  • ICH Q8; Pharmaceutical Development
The three stages of process validation and what must be done during each stage.
  • Stage 1; Process Design
  • Stage 2; Process Qualification
  • Stage 3; Continued Process Verification
The extension of the concept of process life-cycle to test method validation. Attendees will better understand contemporary expectations for process validation and how these support the quality system approach to compliance.

Who Must Attend: 

  • Branded and generic pharmaceutical firms
  • Contract pharmaceutical manufacturesManagement at all levels who are responsible for process development and validation
  • Personnel who are responsible for
  • Product development
  • Process transfer
  • Process validation
  • Demonstration that a process continues to perform in a state of control,
  • QA, personnel who are responsible for the review and approval of process validation protocols and reports
  • Validation specialists

Instructor:

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and has managed Analytical Research, Quality Control and Quality Assurance functions for major pharmaceutical firms.

Since 1994 Dr. Lanese has been an independent consultant.  He has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.

Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers.  In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance and he is the co-author of a continuing series of articles in the Journal of GXP Compliance, “GXP Talk”. 

Available Options

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

$2,659

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

$4,789

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$809

Related Products

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Why should you attend:Medical Device managers, engineers, QA personnel, as well as lean program leaders.Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in ..

$279

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

Computer System Validation Requirements

Computer System Validation Requirements

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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 Attendance CertificateDescription: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many..

$259

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Description:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integr..

$279

FDA's Add-On Inspections for 21 CFR 11

FDA's Add-On Inspections for 21 CFR 11

Description:In December 2010 FDA started the Part 11 inspection initiative. This has now led FDA to stepping up 21 CFR 11 inspections with the result that 21 CFR 11 citations are rising algorithmically and have become a favorite area for inspection violations. This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violat..

$279

Gaining and Re-establishing Control of your Clean Room

Gaining and Re-establishing Control of your Clean Room

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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. Description:This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and brin..

$269

Requirements of Validation – IQ, OQ and PQ Protocols

Requirements of Validation – IQ, OQ and PQ Protocols

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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.Certifications: GRCTS Attendance CertificateDescription:Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation.  You’ll lear..

$259

Investigating OOS and OOT Results

Investigating OOS and OOT Results

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar 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. Description:This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the at..

$259

Process Validation for Drugs and Biologics

Process Validation for Drugs and Biologics

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Description:This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems s..

$279

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

The price for the recording is a discounted figure since the recording has a bit of static. The audio of the expert is loud and clear. However, due to static within the meeting. We are obligated to offer the recording at a discounted price. Please contact our support@grcts.com or click on chat below if you have any questions. Why should you attend:If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often red..

$269

Move From An Operational Manager to A Strategic Leader - HRCI and SHRM credits 1.5

Move From An Operational Manager to A Strategic Leader - HRCI and SHRM credits 1.5

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. Certifications: SHRM PDCs - 1.5GRCTS is recognized by SHRM to offer Professional Development Credits (PDCs) for the SHRM-CPSM or SHRM-SCPSM. This program is valid for [1.5] PDCs for the SHRM-CPSM or SHRM-SCPSM. For more inform..

$259

New Pharma Water System Project Details

New Pharma Water System Project Details

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 Attendance CertificateDescription:All Pharma Water systems have FDA established Standards for drug manufacturing. Included are Chemical and Microbial limits, Sampling, Testing, Materials, Records, Reports, In..

$389