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- #Medical
OVERVIEW
The
benefits of applying the QbD principles in the pharmaceutical industry have
been well advertised. Most important are the direct benefits to our primary
customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration “All products are
designed and developed to be of high quality; Quality by Design provides a
structured framework for developing, documenting and presenting development
rationale, experience and knowledge of the formulation and the process, and to
ensure manufacture of products consistently fit for patient use.” Application
of these principles can also benefit the pharmaceutical companies by improving
manufacturing efficiency and promoting innovation.
WHY
SHOULD YOU ATTEND
However,
implementing these principles into the pharmaceutical development culture can
be challenging. QbD involves a complex set of interactions, technologies and
systems that are not easy to grasp. This quality by design training will
explain the main principles behind a QbD approach and provide guidelines on how
to implement the concepts into a pharmaceutical development organization.
Topics covered will include the target product quality profile, risk
assessment, methods to establish a design space, and design of a control
strategy. This review will help bridge the gap between understanding the
principles and practical application.
AREAS
COVERED
•
Quality Target Product Profile (QTPP)
• Risk Assessment
• Using Models
• Design of Experiments
• Developing a Design Space
• Process Analytical Technology (PAT)
• FMEA and Control Plan
• Target Operational Profile
• Control Strategy
LEARNING
OBJECTIVES
This
training will explain the main principles behind a QbD (Quality by Design)
approach and provide guidelines on how to implement the concepts into a
pharmaceutical development organization.
WHO
WILL BENEFIT
This
course is designed for people tasked with developing, filing, and manufacturing
pharmaceutical products especially small molecule oral dosage forms. This
includes individuals that have responsibilities for formulation development,
scale-up, filing, and commercial manufacture of dosage forms as well as
maintaining the high quality of those products. Following personnel will
benefit from the course:
• Senior Quality Managers
• Quality Professionals
• Regulatory Professionals
• Compliance Professionals
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Development Professionals
• Senior Development Managers
SPEAKER
Steven Laurenz, Principal Consultant – BioPhia Consulting
Inc., has over 25 years of technical leadership experience in product
development, process development, technology transfer, and process
optimization. He is skilled in taking new products from early laboratory stage
to successful manufacturing launch.
Use Promo Code XMSNY19 and get flat 20% discount on
all purchases.
To Register (or) for more
details please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882