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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
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      • Medical Devices
      • Regulatory
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HomeManufacturing & Good Manufacturing Practices (GMP) TrainingQuality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

Teachers
Joanna Gallant
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The ICH documents Q8, Q9, and Q10 have been gaining attention recently with the new FDA quality metrics initiative and the announcement of the FDA’s pilot program for training inspectors to assess a quality culture . This means that expectations set in these guidances won’t be optional for much longer, and organizations must assess their own operations for “Quality by Design” (QbD) compliance.

This process is confusing for many companies because it’s a very different way of thinking and working. Although the three documents are written as standalone entities, in order to implement them, all three must be used together.  And worse, there are other guidances (like FDA’s Process Validation Guidance) and requirements (like the cGMPs) that have to be factored into the process. Furthermore, if one part of the organization is ready and another isn’t, the process defined in Q8, Q9, and Q10 will run into difficulties.

Spending the time to incorporate the latest QbD expectations into your operations is critical.

LEARNING OBJECTIVES

In this interactive, 90-minute webinar you will learn:

  1. The differences between the old GMP mindset and the new quality systems mindset – and how they both affect our daily operations
  2. What each guidance covers, including scope and applicability to the various parts of the operations
  3. All of the parts required for an effective quality system (per these guidances and regulations), and how the systems should interact
  4. How to assess your own site processes and systems against the guidances

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale.  This includes quality, validation, manufacturing, development and all management personnel from sponsors and contract manufacturers (CMO) alike.

What To Expect

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.

About Instructors

Joanna Gallant
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing & Good Manufacturing Practices (GMP) Training (92)
  • Medical Device Training (63)
  • On-Demand Courses (239)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

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About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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Course Categories

  • Clinical Trials & Good Clinical Practices (GCP) Training
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