Understanding and Implementing a Quality by Design Program

6 years ago Posted By : User Ref No: WURUR24387 0
  • Image
  • TypeWebinar
  • Image
  • Location Aurora, Colorado, United States
  • Price
  • Date 05-09-2018
Understanding and Implementing a Quality by Design Program, Aurora, Colorado, United States
Webinar Title
Understanding and Implementing a Quality by Design Program
Event Type
Webinar
Webinar Date
05-09-2018
Last Date for Applying
05-09-2018
Location
Aurora, Colorado, United States
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Business Development

Economics

Biotechnology

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

OVERVIEW

The benefits of applying the quality by design in pharmaceutical development 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.

WHY SHOULD YOU ATTEND

However, implementing these principles into the pharmaceutical development culture can be challenging. QbDin pharmaceuticals involves a complex set of interactions, technologies and systems that are not easy to grasp. 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

  • 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 approach and provide guidelines in 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

For more detail please click on this below link:

https://bit.ly/2MtQpP2

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

 

Others Details

Understand the QbD approach to pharmaceutical development including topics like the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy

Registration Fees
Available
Registration Fees Details
Live Session for one participant $199 Corporate Live Session Group – Max 10 Participants from one location. $549 Recorded Session Get unlimited access to the link for six months. $219 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $399 Super Combo Offer 1 Live and Recorded webinar $329 Super Combo Offer 2 Live and Training CD $499
Registration Ways
Email
Phone
Website
Other
Address/Venue
  Training Doyens 26468 E Walker Dr,Aurora, Colorado  Pin/Zip Code : 80016-6104
Landmark
Colorado
Official Email ID
Contact
Training Doyens

Training Doyens 26468 E Walker Dr,Aurora, Colorado

[email protected]

   +1-720-996-1616