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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Webinar Includes :A Copy of the presentation slides,A certificate of participation for attendee training records and 120 mins Live Webinar

" John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System"

ICH guidance documents, US inspectional guidance and how they relate


In 2001 the FDA announced that it would:

• Adopt a Quality Systems model
• Develop Quality Systems guidance
• Implement Risk-Based management plan
• Practice science-based regulation of product quality

This was the beginning of a transition that continues. The FDA guidance and expectations related to process validation are a significant part of the movement to a Quality System approach to compliance.
In the same year, ICH published ICH Q7A which, with the introduction of the term “Quality Management”, signaled the beginning of the transition (Note; ICH Q7 has been updated recently.) Since 2005 ICH has released four guidance documents: ICH Q8, Pharmaceutical Development, ICH Q9, Quality Risk Management, ICH Q10, Pharmaceutical Quality System, ICH Q11, Development and Manufacture of Drug Substances, In 2011, the FDA released the final version of its guidance on Process Validation; Process Validation: General Principles and Practices. Since that time, the European Union published a draft of its Guideline on Process Validation, which has been absorbed into Annex 15, Qualification and Validation. None of these guidance documents are stand-alone. They are interdependent and each heavily references the others. Therefore, it is important that individuals in all areas of the pharmaceutical firm that are involved with any part of the product lifecycle be aware of these guidances and understand how they relate to one another.

In this live training webinar we will discuss the ICH guidance documents, US inspectional guidance and how they relate to and impact the US and EU guidance on process validation. At the core of these guidance documents is ICH Q10, Pharmaceutical Quality System. It establishes the concept of product lifecycle. Although ICH Q8, Pharmaceutical Development, focuses on the product/process development phase of the lifecycle, it includes activities found throughout the product lifecycle. ICH Q9, Quality Risk Management, advocates the application of risk evaluation and management through all stages of product lifecycle. ICH Q11, Development and Manufacture of Drug Substances, combines the elements found in QCH Q8, Q9 and Q10 and applies them to a specific process, the development of a drug substance.

Finally, we will discuss a recent FDA guidance Quality Metrics, and how it will increase the visibility of each pharmaceutical firm’s validation program to the FDA and how the requirements driven by the Quality Metrics program can be integrated into the firm’s validation program and other quality systems.

Webinar outline and time breakdown: 

Time 10:15 AM

Log In Period10:30 AM

Introduction10:40 AM
Terminology: Lifecycle, ICH Q10, Q8, Q9 and Q11,Relationship between ICH Q8, Q9 and Q10,ICH Q10 the product lifecycle and validation,ICH Q8 the product lifecycle and validation,ICH Q9 the product lifecycle and validation,ICH Q11 the product lifecycle and validation,The FDA process validation guidance and the stages of process validation

11:30 AM Break

11:40 AM

Integrate the guidances,Process validation through the lifecycle,Impact of the EU process validation guidance

12:30 PM

Live Questions & Discussion

Areas Covered

•    Understand the basic concepts found in ICH Q8, Q9, Q10 and Q11. 
•    Understand how the FDA process validation guidance supports the lifecycle concepts.
•    Understand the interdependence of all of the guidances.
•    Understand how the life cycle concepts apply to the stages of process validation.
•    Be able to develop a systematic approach to process validation that will include all of the concepts found in ICH         Q8, Q9 and Q10.

Who will Benefit

The following individuals or disciplines will benefit from attending this Webinar:

•    Senior management
•    Production management
•    Quality management
•    Quality Assurance
•    Quality Assurance Product Reviewers
•    Regulatory

Industries who can attend

This 120-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

John G. Lanese

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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry

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