Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process


26 jul, 2018 – 1:00 P.M. - 2:30 P.M.

This is an Online Webinar
Bethesda, MD 20817 Mapa

Mas Información

   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 lifecycle approach into the development and
validation of new processes and the verification of the validation of old processes.

Objective :

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

Areas Covered in the Session

   1: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 

   2: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 

   3:The extension of the concept of process
lifecycle to test method validation.

   Attendees will better understand contemporary
expectations for process validation and how these support the quality system
approach to compliance.

Who Will Benefit:

   1:Management at all levels who are
responsible for process development and validation

   2:Personnel who are responsible for 

  •          Product development
  •          Process transfer
  •          Process validation
  •          Demonstration that a process continues to perform in a state
    of control 

   3:QA, personnel who are responsible for the
review and approval of process validation protocols and reports

   4:Validation specialists.

About Speaker:

   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 began his career
teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved
from the academic environment to the pharmaceutical industry where he has
managed Analytical Research, Quality Control and Quality Assurance functions.

   In 1994 Dr. Lanese formed his own company,
The Lanese Group, and since that time he has been a consultant in the area of
quality system and cGMP compliance and has audited and 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 focuses on training. 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.

Event URL:


Organizer: Compliance Training Panel



Phone: 844-216-5230


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