Fundamentals and Essentials of Validation
Time and cost-saving strategies for pharmaceutical
and active pharmaceutical ingredient manufacturers
On this page...
Benefits of attending for
you and your company
At the end of the course you will... |
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understand how validation can save the company money
and help rapidly bring products to market |
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be acutely aware of what specifics the regulatory
authorities deem key to effective validation |
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know the pitfalls of validation and how to avoid
them |
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be knowledgeable in all aspects of the validation
process |
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appreciate the complexity of validation and the contribution
various disciplines can bring to ensuring validation
is completed efficiently and cost effectively |
Who Should Attend
This course is intended for quality assurance, engineering,
production, quality control and product development
personnel who are all intimately involved in the validation
effort. This course will be of special interest to
all managers trying to establish a cost-effective
approach to organizing the validation effort and to
those personnel responsible for performing validation.
Course Langauge
English
Course Overview
Validation has become the most complex, costly and
time-consuming aspect of all the activities a healthcare
manufacturing company must perform in order to comply
with good manufacturing practices (GMP). Why do we
do it? What are the benefits? How can we do it cost-effectively
and efficiently?
Regulatory authorities, in their effort to protect
the health and safety of patients, insist that validation
be performed in all areas of product development,
production and quality control testing. This course
covers all the elements of the five key validations
required by manufacturers to satisfy regulatory authorities
(including the United States FDA): process validation,
cleaning validation, utilities validation, computer
validation and analytical method validation.
The course presents the four qualification phases
of validation (DQ, IQ, OQ, and PQ) and the five different
validations in a logical and organized manner. The
course describes exactly what is required to be performed,
how to plan for validation and who in the company
should carry out which aspects of the validation exercise.
Drawing on worldwide experience in validation activities,
the course presents examples of companies performing
validation right and companies performing validation
wrong. Validation, efficiently managed, provides significant
benefits and cost savings to companies, in addition
to allowing speedy product and facility approval during
government inspections.
Course Outline
| Overview and background |
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What is validation? Why is it required? What are
the regulations, international regulatory requirements
(United States FDA, European Union, Japan, ISO-9000)
and industry trends? The cost of validation. |
| Concepts and terms |
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Definitions and requirements of: metrology (calibration),
protocols, design qualification, installation qualification,
operational qualification, performance qualification,
validation, recovery testing, validation master plan,
retrospective validation, concurrent validation, prospective
validation, acceptance criteria, validation summaries,
reports and life cycles. |
| Process validation |
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Requirements and techniques involved with validation
of:
— Active pharmaceutical ingredients (APIs)
— Pharmaceuticals (sterile and non-sterile)
— Biotechnology products |
| Cleaning validation |
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How clean is clean? Cleaning validation requirements;
cleaning validation methodology; recovery testing
techniques; calculating cleaning limits (MACO, MARS). |
| Analytical method validation |
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The seven essential elements of analytical method
validation: accuracy, precision, selectivity, specificity,
linearity, limits of detection, limits of quantitation
and ruggedness. The role of research and development
in validation. Technology transfer documents and development
reports. Laboratory equipment qualification. |
| Utilities validation |
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Validation of: air conditioning (HVAC) systems, compressed
air systems, purified water and water for injection
systems, steam systems, electrical and gas systems. |
| Computer validation
and 21CFR Part 11 Compliance (electronic records) |
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When is a computer a computer, and
when does it need validating? Validation of computer
hardware (personal computers, PLCs, etc.); software
validation. Approaches to validating commercially available
software and in-company developed software. Software
validation development life cycles; international standards
for software validation; 21CFR11 compliance issues.
Where exactly is FDA in its requirements for compliance
with the electronic record/signature regulations (21CFR11)? |
| Case study |
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Work in groups to develop an FDA acceptable validation
study: DQ/IQ/OQ/PQ — the lot. |
Previous Participant Testimonials
I just wanted to drop you a line to say thank you for a very useful and
interesting seminar. I know that my company got the most bang for their buck with all the questions that you answered for me. It was a pleasure... and the lunches were great!
Melanie Cerullo
Thank you for a great course and your insight over the past 2 days! I wish I could have spent more time really asking further in depth question but time and travel intervened. Thanks again.
H. Kriss, SIAL
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