w w w .r eal l tgreatsi te.

c o m

THE COMPLEXITY OF
PROCESS
VALIDATION
 What Does It Take To Complete Process Validation
The time it takes to complete a
process validation depends on
several factors, such as the
type and complexity of the
process, the number and size of
the batches, the availability
and quality of the data, and the
regulatory requirements.
According to some sources, the
average amount of time for
processing and resolving new
incidents with acceptable,
correct documentation is
typically 14 business days.
However, validation can take
much longer in some cases,
especially if there are any
issues or deviations that need
to be addressed.
For example, validation of a
sterile package sealing process
may take several months,
while validation of a welding
process may take only a few
weeks.
There are also different types
of process validation,
depending on the stage of
development and production.
These are:
Prospective validation:
This is carried out during
the development stage,
before the product is
marketed. It involves
designing and testing the
process based on scientific
principles and data and
establishing a strategy for
process control.
Concurrent validation: This is
carried out during normal
production, after the product is
approved. It involves monitoring
and testing the process
performance and product quality in
real time and verifying that the
process remains in a state of
control.
Retrospective validation: This is
carried out after the product has
been in the market for some time,
using historical data and records. It
involves analyzing the consistency
and reliability of the process over
time, and identifying any potential
sources of variation or deviation.
Revalidation: This is carried out
periodically or after any change
that may affect the process or
product. It involves repeating some
or all of the validation activities to
confirm that the process remains
valid and capable of producing a
quality product.

Borcelle | Page 4
About us
CoursWorx is an online community for Validation and Regulatory
Compliance Professionals working in FDA-regulated industries.

Vision
In a world where people long for
human interaction, learning is a
constant connector. Give yourself and
your workforce new ways to connect,
learn critical skills, and share learning
through our online community.
Mission
We’re on a mission to empower
validation and regulatory
professionals who work in life
science. If you’re looking to enhance
your career opportunities, expand
your network, and learn new skills,
then CoursWorx is for you.

Subscribe
With over 12,000 LinkedIn
members, CoursWorx is one
hallmark of a professional.
Subscribing to CoursWorx
can help you along your
journey as a professional –
no matter where you are in
your career.
THREE STAGE APPROACH
The FDA recommends a three-stage approach to process validation, which consists of process
design, process qualification, and continued process verification.

Objectives, Activities and Deliverables

Each stage has its own objectives, activities, and deliverables, and may require different
amounts of time and resources. For example, process design may take longer than process
qualification, as it involves building and capturing process knowledge and understanding,
and establishing a strategy for process control.

Verifying, Monitoring and Evaluating

Process qualification may take less time than process design, as it involves verifying that the
process operates within the defined parameters and produces a quality product.

Continued process verification may take the longest time, as it involves monitoring and
evaluating the process performance and product quality throughout the product lifecycle.
ACCURATE, PRECISE
AND VALIDATED
The time it takes to complete a
process validation also depends
on the analytical methods and
tools used to collect and evaluate
the data.

The analytical methods and tools

should be appropriate, accurate,
precise, reliable, and validated
for the intended use.

The data should be sufficient,

relevant, and representative of
the process and product.
The data analysis should be
rigorous, objective, and
statistically sound.

The data should be documented and reported in a clear, concise, and consistent manner. If you
want to learn more about process validation and how long it takes, you can register for our webinar
at https://www.linkedin.com/events/lifescienceprocessvalidationgui7150110738261430272

Program Title: Life Science Process Validation Guidance: New Concepts, Purpose And Insight
Program Date: February 22, 2024, at 1:30 pm EST
Program Sponsor: CoursWorx
Presenter: Stephanie Brandford, Founder of Brayearst Validation Consulting
 WEBINAR DETAILS
Join us for an exclusive
educational seminar on Process
Validation and gain critical
insights that can shape the future
of your work:
A Can't-Miss Event
Process validation is a requirement but
knowing when to validate or revalidate
a process is essential. If you do not
validate risk properly, you may face
enforcement actions such as fines or
recalls.
However, too much validation is costly
in both time and money.
This webinar will cover the basics of
this important topic for those who are
new to quality or new to process
validation.
The process validation webinar will
touch on the following topics as an
orientation.
· Overview of Process Validation:
Understand the concept of process
validation, its purpose, and its scope
within quality management systems.
This sets the foundation for your
journey.
· Processes Requiring Validation: Gain
clarity on which processes typically
require validation, emphasizing special
processes with real-life examples for
practical insight.
· Conducting a Validation - Key Stages:
Dive deep into the three critical stages of
validation: Installation Qualification (IQ),
Operational Qualification (OQ), and
Performance Qualification (PQ). This is
the core of process validation.
· Maintaining a State of Validation:
Discover strategies for monitoring and
controlling processes post-validation,
addressing changes in process or
product, and knowing when revalidation
might be necessary.
· Summary of Validation Activities:
Conclude with a summary of the key
activities and takeaways in process
validation, reinforcing the primary
learning objectives you can apply
immediately.
 Learning
Objectives
Learn why process validation is
not just a requirement but a
strategic imperative.
Understand the key stages and
criteria for successful process
validation.
Gain insights into maintaining a
State of Validation for ongoing
compliance.

Areas Covered in the Who Will Benefit:

Webinar:
The significance of process Validation Specialists
validation Quality Engineers
Compliance requirements and Manufacturing Engineers
guidelines Regulatory Compliance Experts
Identifying processes requiring Quality Managers new to medical
validation devices or process validation
In-depth exploration of validation Operations/Manufacturing
stages Managers new to medical devices
Strategies for post-validation or process validation
process control Medical device consultants new to
process validation
Stephanie
Brandford

Presenter

Stephanie Brandford commenced her Upon transitioning from the chemical

professional journey after earning a
bachelor's degree in chemical
engineering from Carnegie Mellon
University. In her initial engineering
roles, she engaged in tasks related to
regulatory compliance for the
Environmental Protection Agency,
while also applying statistical process
control methodologies within the
realm of manufacturing processes.
industry to the medical device sector,
she adeptly transferred these skills
into an entirely new career trajectory.
Functioning as a validation engineer,
Stephanie skillfully employed her
compliance-driven mindset to meet
the exacting requirements set forth
by the Food and Drug Administration.

Following her transition to a new employer, she further enriched her statistical foundation
by successfully obtaining certification as a Six Sigma Black Belt. Throughout her tenure,
she leveraged these technical proficiencies while simultaneously broadening the scope of
her responsibilities.

As Stephanie’s journey with the organization progressed, she ascended to a leadership role
overseeing a team of validation engineers dedicated to diverse projects spanning multiple
areas of manufacturing.

As founder of Brayearst Validation Consulting, Stephanie brings a wealth of experience in

regulatory compliance and statistical process control. With a background in chemical
engineering and Six Sigma Black Belt certification, Stephanie has excelled in various areas
of validation, offering practical insights to a global audience. Join Stephanie on February
22, 2024, for an enriching webinar experience.