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  1. Courses
  2. Stability Testing 101

Stability Testing 101

Welcome

Stability profile is determined to be the critical quality attributes of drug substance and drug products. This course is intended to provide a basic to advanced level understanding on developing a stability program to support the expiration dating of pharmaceutical products. Content will focus on different aspects from development to commercial to understand the stability profile of drug substance and drug products. In addition, a thorough update of recent and emerging techniques used to establish the integrity, strength, quality and purity of drug products will be provided.

Course Objectives

After completing this online course, the user will be able to:
  • Identify and discuss the current regulations globally required for a stability program to support expiration dating and use periods of drug products/API
  • Describe requirements for stability indicating methods
  • Monitor impurities in API and drug products
  • Identify/set stability specifications and change controls
  • Review, evaluate and discuss stability data
  • Create a stability report and CMC documents
  • This course is identified as a knowledge educational activity.
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

Purchase Now
Purchase the entire course—all 14 lectures—at an even greater discount by clicking the button below. Interested in just a lecture or two? Scroll down to add lectures to your cart individually. 

 ($660.00-$1,269.00)

$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 1: Introduction to Stability Testing

Presentation: Radhika Rajagopalan, Ph.D. , 30 min 34 sec

Assessment- Lecture 1

Assessment: 8 questions 5 retakes

Evaluation - Lecture 1

Survey: 13 questions

Introduction to Stability Testing

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 2: Regulations on Stability Program Global Stability Requirements

Presentation: Yan Wu, Ph.D., 40 min 26 sec

Assessment- Lecture 2

Assessment: 7 questions 5 retakes

Evaluation - Lecture 2

Survey: 13 questions

Regulations on Stability Program Global Stability Requirements

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 3: Quality by Design Approach for Stability

Presentation: Jianmei Kochling, Ph.D. , 42 min 49 sec

Assessment- Lecture 3

Assessment: 7 questions 5 retakes

Evaluation - Lecture 3

Survey: 13 questions

Quality by Design Approach for Stability

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 4: Development and Validation of Stability-Indicating Methods

Presentation: Kim Huynh-Ba, M.S., PMP, 76 min 9 sec

Assessment- Lecture 4

Assessment: 10 questions 5 retakes

Evaluation - Lecture 4

Survey: 13 questions

Development and Validation of Stability-Indicating Methods

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 5: Monitoring Organic Impurities during Stability Program (API and Drug Product): Stress Testing Industry Best Practices

Presentation: Karen Alsante, Ph.D. , 64 min 38 sec

Assessment- Lecture 5

Assessment: 7 questions 5 retakes

Evaluation - Lecture 5

Survey: 13 questions

Monitoring Organic Impurities during Stability Program (API and Drug Product): Stress Testing Industry Best Practices

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 6: Photo-stability Testing and Q1B

Presentation: Lee Klein, Ph.D. , Leonardo Allain, Ph.D. , W. Peter Wuelfing, Ph.D. , Allen Templeton, Ph.D. , 69 min 23 sec

Assessment- Lecture 6

Assessment: 9 questions 5 retakes

Evaluation - Lecture 6

Survey: 13 questions

Photo-stability Testing and Q1B

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 7: Stability of Parenterals

Presentation: Mark Alasandro, Ph.D. , 27 min 4 sec

Assessment- Lecture 7

Assessment: 10 questions 5 retakes

Evaluation - Lecture 7

Survey: 13 questions

Stability of Parenterals

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 8: Stability Expectations for Generic Drugs (ANDAs)

Presentation: Radhika Rajagopalan, Ph.D. , 36 min 55 sec

Assessment- Lecture 8

Assessment: 8 questions 5 retakes

Evaluation - Lecture 8

Survey: 13 questions

Stability Expectations for Generic Drugs (ANDAs)

Certificate: 0/3 Course items completed
$59.00 - $129.00
Non-Member
$129.00
Member
$109.00
E-Subscriber
$129.00
Student
$59.00

Lecture 9: Stability Program for Biologics

Presentation: Tony Mazzeo, Ph.D. , 26 min 27 sec

Assessment- Lecture 9

Assessment: 7 questions 5 retakes

Evaluation - Lecture 9

Survey: 13 questions

Stability Program for Biologics

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 10: Bracketing and Matrixing of Stability Testing (Q1D)

Presentation: J. Brooke Marshall, Ph.D. , 52 min 15 sec

Assessment- Lecture 10

Assessment: 10 questions 5 retakes

Evaluation - Lecture 10

Survey: 13 questions

Bracketing and Matrixing of Stability Testing (Q1D)

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 11: Evaluation of Stability Data (Q1e)

Presentation: Nanda Subbarao, Ph.D., 47 min 6 sec

Assessment- Lecture 11

Assessment: 9 questions 5 retakes

Evaluation - Lecture 11

Survey: 13 questions

Evaluation of Stability Data (Q1e)

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 12: Using Stability Data to support Specification Setting (ICH Q6A)

Presentation: Dilip Choudhury, Ph.D. , Robert Timpano, 40 min 2 sec

Assessment- Lecture 12

Assessment: 9 questions 5 retakes

Evaluation - Lecture 12

Survey: 13 questions

Using Stability Data to support Specification Setting (ICH Q6A)

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 13: Investigations of OOS/OOT

Presentation: Paula Youngberg Webb, M.S. , 40 min 35 sec

Assessment- Lecture 13

Assessment: 7 questions 5 retakes

Evaluation - Lecture 13

Survey: 13 questions

Investigations of OOS/OOT

Certificate: 0/3 Course items completed
$59.00 - $129.00
Student
$59.00
E-Subscriber
$129.00
Member
$109.00
Non-Member
$129.00

Lecture 14: Stability to Support Post Approval Changes

Presentation: Frank Diana, Ph.D. , 61 min 23 sec

Assessment- Lecture 14

Assessment: 9 questions 5 retakes

Evaluation - Lecture 14

Survey: 13 questions

Stability to Support Post Approval Changes

Certificate: 0/3 Course items completed
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