Writing and Managing SOPs for GCP 1st edition by Susanne Prokscha – Ebook PDF Instant Download/Delivery: 1040071007 , 9781040071007
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Product details:
ISBN 10: 1040071007
ISBN 13: 9781040071007
Author: Susanne Prokscha
This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management.
Writing and Managing SOPs for GCP 1st Table of contents:
Section I: Founding Principles
Chapter 1: Introduction to SOPs
1.1 What is an SOP?
1.2 Why do we have SOPs?
1.2.1 GCP Requires SOPs
1.2.2 The Organization Needs Them
1.3 Why Do We Follow SOPs?
1.4 Beyond SOPs
1.4.1 Say What We Do, Do What We Say
Chapter 2: Document Hierarchies
2.1 Controlled Documents and Managed Documents
2.2 Overview of the Hierarchy
2.3 More About Controlled Document Types
2.3.1 SOP of SOPs
2.3.2 SOPs
2.3.3 Forms and Templates
2.3.4 Work Instructions and Manuals
2.4 More About Managed Document Types
2.4.1 Department-Managed Documents
2.4.2 Training Materials and Curricula
2.4.3 Data Standards
2.4.4 TMF Reference Models
2.4.5 Process Flow Diagrams
2.4.6 Other Document Types
2.5 Where Are the Policies?
2.6 Where Are Guidance Documents?
2.7 Hard-to-Classify Documents
2.8 SOP of SOPs
Chapter 3: When to Have an SOP
3.1 Does It Belong in an SOP?
3.2 Is It Required by GCP?
3.3 Does It Support Other Regulations?
3.4 Is It a Business Need?
3.5 Benefiting Both Compliance and Business
3.6 When an SOP Is Not Needed
3.7 Other Ways to Introduce Consistency
3.8 SOP of SOPs
Chapter 4: What the SOP Should Say
4.1 Who, What, When, and Where
4.1.1 Who and What
4.1.2 When and Where
4.2 How and the Level of Detail
4.3 Cover One Topic or Many Topics?
4.4 Too Many or Too Few SOPs
4.5 SOP of SOPs
Chapter 5: Where to Put the Output
5.1 What Is a Trial Master File?
5.2 Contents of a TMF
5.3 Overview of the DIA TMF Reference Model
5.4 Company TMF Reference Models
5.5 Paper TMFs and Electronic TMFs (eTMFs)
5.6 The TMF Connection to SOPs
5.7 Not All Documents Belong in the TMF
5.8 SOP of SOPs
Section II: Writing, Reviewing, Approving, and Posting
Chapter 6: Who Writes SOPs?
6.1 Which Department Provides the Author?
6.2 Selecting an Author
6.3 Clinical Development’s Controlled Document Group
6.4 SOP of SOPs
Chapter 7: Document a Stable Process
7.1 SOPs Should Not Be Theoretical
7.2 Testing a Procedure
7.3 Draft and Vet the Process
7.4 Assess the Need for Deviations
7.5 Select Studies
7.6 Document the Process Used
7.7 When You Cannot Pilot
7.8 SOP of SOPs
Chapter 8: Mapping a New Process
8.1 Assemble a Team
8.2 Review Regulatory Requirements
8.3 List Steps or Actions in the Right Order
8.4 Who Is Responsible? Who Is Involved?
8.5 Identify Inputs and Outputs
8.6 Be Aware of Sequence and Prerequisites
8.7 Translate the Process into an SOP
8.8 Stay Aligned with Any Approved Process Maps
8.9 SOP of SOPs
Chapter 9: The SOP Template
9.1 Document Header
9.1.1 Title
9.1.2 Document Identifier
9.1.3 Effective Date
9.1.4 Version Number
9.2 Purpose and Scope
9.2.1 Purpose
9.2.2 Scope
9.3 Definitions and Background
9.4 Responsibility
9.5 Procedure
9.5.1 Outline Format
9.5.2 Table Format
9.5.3 Roles That Cannot Appear in Procedures
9.6 Document Disposition
9.7 References
9.8 Appendices
9.9 Revision History
9.10 Other Considerations
9.10.1 Formatting
9.10.2 Template Updates
9.11 SOP of SOPs
Chapter 10: SOP Review and Approval
10.1 Concentric Rings of Review
10.1.1 Expert Review
10.1.2 Function or Department Review
10.1.3 Cross-Functional Review
10.1.4 Compliance Review
10.1.5 Approver Review
10.1.6 Controlled Document Group Review
10.2 Best Practices for Review
10.3 Preparing Documents for Review
10.4 Sending Out for Review
10.5 Tracking Reviews and Reviewers
10.6 Adjudicating Feedback
10.7 Approval
10.8 How Long Does This Take?
10.9 Reviewing Documents from Other Departments
10.10 SOP of SOPs
Chapter 11: Posting—Setting Up for Success
11.1 Is It Really Ready to Post?
11.2 Communication Plans
11.2.1 Preparation
11.2.2 Communication Plan Options
11.3 SOP Release Cut-Over Rules
11.3.1 Why Do We Need Rules?
11.4 Implementation Memos
11.5 Posting SOPs
11.6 SOP of SOPs
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Tags: Susanne Prokscha, Managing SOPs, Writing