Home Page Icon
Home Page
Table of Contents for
Cover image
Close
Cover image
by G Welty
Quality Assurance
Cover image
Title page
Table of Contents
Copyright
List of figures
List of tables
List of abbreviations
About the author
Acknowledgments
Part I: A systematic approach to problem solving
Introduction
Chapter 1: Framework for continuous improvement
Abstract:
1.1 Introduction
1.2 Procedures and change
1.3 Routine review of life-cycle documents
1.4 Intervention due to internal observation
1.5 Intervention due to external observation
1.6 Conclusion
Chapter 2: Investigations, root cause analyses and CAPAs
Abstract:
2.1 Triage and escalation
2.2 The process of investigation
2.3 The process of CAPA
2.4 Conclusion
Chapter 3: The role of critical review in the revision of procedures
Abstract:
3.1 Introduction
3.2 Overview of critical review of SOPs
3.3 Risk assessment and critical review
3.4 Investigating a complex × critical problem
3.5 Conclusion
Chapter 4: Working with standard operating procedures (SOPs)
Abstract:
4.1 Introduction
4.2 The process of cleaning and sanitizing of facilities
4.3 An illustrative example of a cleaning and sanitizing SOP
4.4 Conclusion
Chapter 5: The design phase of the program improvement model
Abstract:
5.1 The ADDIE model and the program improvement model
5.2 The training module in the larger curriculum
5.3 Outlining the proposed training module
5.4 Conclusion
Part II: Designing and developing training materials
Introduction
Chapter 6: Content development: a new employee orientation program
Abstract:
6.1 Introduction
6.2 NEO and the Employment Life-cycle
6.3 A typical NEO program
6.4 Regulatory overlap and its implications
6.5 Presenting the history of the FDA
6.6 Organizational issues
6.7 Conclusion
Chapter 7: Content development: a continuing cGMP training program
Abstract:
7.1 Introduction
7.2 Regulations call for continuing cGMP training
7.3 Who are the qualified individuals?
7.4 Applicable cGMP requirements
7.5 Logistics of continuing cGMP training
7.6 Conclusion
Chapter 8: Content development: qualification of employees
Abstract:
8.1 Introduction
8.2 Regulatory basis for training
8.3 Categories of training
8.4 Qualification considerations
8.5 The rationale for qualification
8.6 Disqualification and requalification
8.7 Conclusion
Part III: Using the training materials
Introduction
Chapter 9: Assessing trainee proficiency
Abstract:
9.1 Introduction
9.2 Behavioral objectives in the training module
9.3 Which kind of assessment
9.4 Preparing the assessment materials
9.5 Incorporating assessments into the training module
9.6 Conclusion
Chapter 10: Pilot implementation
Abstract:
10.1 Pilot implementation and the program improvement model
10.2 Pilot projects in the pharmaceutical industry
10.3 Conditions facilitating implementation
10.4 Obstacles to implementation
10.5 Preparing for a pilot implementation
10.6 Conducting a pilot implementation
10.7 Evaluating a pilot implementation
10.8 Conclusion
Chapter 11: Training record-keeping
Abstract:
11.1 Introduction
11.2 Record-keeping requirements
11.3 Part 11 compliance
11.4 Tactics of training record-keeping
11.5 The training unit as audience
11.6 Conclusion
Chapter 12: Formative evaluation
Abstract:
12.1 Introduction
12.2 Feedback versus research design
12.3 The good news, part 1
12.4 The coexistence of RCT and dissemination of results
12.5 The good news, part 2
12.6 Management’s prerogative
12.7 Conclusion
Chapter 13: Final implementation
Abstract:
13.1 Introduction
13.2 Scope and impact of FDA regulations
13.3 The typical organizational response
13.4 The role of the target audience list
13.5 Conclusion
Index
Search in book...
Toggle Font Controls
Playlists
Add To
Create new playlist
Name your new playlist
Playlist description (optional)
Cancel
Create playlist
Sign In
Email address
Password
Forgot Password?
Create account
Login
or
Continue with Facebook
Continue with Google
Sign Up
Full Name
Email address
Confirm Email Address
Password
Login
Create account
or
Continue with Facebook
Continue with Google
Next
Next Chapter
Title page
Add Highlight
No Comment
..................Content has been hidden....................
You can't read the all page of ebook, please click
here
login for view all page.
Day Mode
Cloud Mode
Night Mode
Reset