Understanding and Implementing a Quality by Design Program


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 ........

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; 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.

Why should you attend this webinar?

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.

Areas Covered in the Session:

ObD principles discussed include

Who can 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:



Webinar Id: LSHCSL010

Training Options:

Duration: 60 mins

 09/25/2018

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

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