Live Webinar Implementing a Quality by Design program for product development

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Description

Join This course On April 6, 2017  at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

This training will explain the main principles behind a QbD approach and provide guidelines in 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.

Why should you Attend:

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 QbD 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. 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.

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

Who will Benefit

-- 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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Steven Laurenz

Steven Laurenz

Steven Laurenz– Chemical Engineering M.S. – Michigan State University

Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortiums.

Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics

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