Quality by Design (QbD) in Clinical Trials – Build Bullet-Proof Protocols
$279.00 – $2,550.00
This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.
Description
COURSE DESCRIPTION
OVERVIEW
Clinical trial quality ultimately rests on having a well-articulated investigational plan with clearly defined objectives and associated outcome measures. Quality-by Design (QbD) emphasizes building quality into a process from the beginning, and has been successfully utilized in the manufacturing arena. Applied in clinical development, this approach examines the design and objectives of a trial protocol to identify “Critical to Quality (CTQ)” factors (e.g. key data and trial processes). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing risks to trial quality.
This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.
LEARNING OBJECTIVES
Attend this 90-minute session, and you will:
- Learn QbD techniques that you can implement immediately to improve trial quality
- Understand Critical to Quality (CTQ) parameters, and build trial protocols that get results
- Mitigate risks and avoid potentially costly pitfalls and rework
WHO SHOULD ATTEND
This interactive online course will be highly beneficial to anyone in clinical development and/or clinical research. Those with responsibilities that include protocol development and design – and ensuring trial quality – will find this training particularly useful.
WHAT TO EXPECT
HOW TO PARTICIPATE
This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.
USER AGREEMENT
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.
Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.
Additional information
| Format | Recorded Only |
|---|---|
| Participants | Single Participant, 5 Participant Value Package, 10 Participant Value Package |
Related products
-
How to Write SOPs that are GCP Compliant and Implementable
$279.00 – $2,550.00 Read more -
Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys!
$279.00 – $2,550.00 Select options -
Using Social Media for Patient Recruitment in Clinical Trials
$279.00 – $2,550.00 Select options -
Change Management Plan Development for Risk-Based Clinical Studies: From Site Monitoring to Vendor Management and Beyond
$279.00 – $2,550.00 Select options
Reviews
There are no reviews yet.