Skip to main content

Understanding and Implementing a Quality by Design Program

ComplianceKEY -  Regulatory compliance training
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
  • 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 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:
  • 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
Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1219&speakerid=203

Compliance Key INC
https://www.compliancekey.us/best-seller
717-208-8666
 
Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

Strategies for Becoming a Business Partner to Your Healthcare Leaders.Compliance Key INC -

Compliance Key INC  -  Healthcare Training Online                                                    Jay Anstine Mr. Anstine's professional background includes working on the provider and the payer side of the market, for large for-profit and non-profit health systems, and small physician-owned entities. In tackling the countless regulatory and operational issues for these diverse organization types, he has developed a deep understanding of the business of healthcare and the regulations that govern the industry.  Webinar Id:  LSHCSJA022  10:00 AM PT | 01:00 PM ET  12/13/2017  Duration 60 mins  Overview All too often compliance is seen as an obstacle or otherwise viewed negatively by healthcare leaders. This presentation will discuss strategies and insights to help the compliance of...
Post a Comment
Read more

HIPAA Changes 2018: How to Comply

Compliance Key INC  -  HIPAA Compliance Training Seminar                                                 Brian L Tuttle Brian Tuttle is Keynote Speaker at Compliance key Inc . He is Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 17 years experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions).  Seminar Id:  IJ2018S2  06:00 AM PT | 09:00 AM ET  02/16/2018  Duration 1 Day Overview This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in ...
Post a Comment
Read more

Motivation Innovation: The Latest on Carrots vs. Sticks

C ompliance Key INC  -  Life science webinars                                               Don R. Powell Don R. Powell is Keynote Speaker at Compliance key Inc.He is the President and CEO of the URAC Accredited American Institute for Preventive Medicine located in Farmington Hills, Michigan. For 33 years the Institute has been a leading developer and provider of health and productivity management programs.   Webinar Id:  LSHCDT001  10:00 AM PT | 1:00 PM ET  12/14/2017  Duration 60min mins  Overview It is one thing to know how to alter one’s behavior, but it is an entirely different matter to be motivated to do so. It is felt that employee motivation is the key factor in determining the success or failure of worksite wellness programs and their ability to reduce health care costs and increase...
Post a Comment
Read more