Writing and managing SOPs for GCP
- Susanne Prokscha.
- Boca Raton : CRC Press, Taylor & Francis Group, 2015.
- Copyright notice
- Physical description
- xvii, 206 pages : illustrations ; 24 cm
At the library
Science Library (Li and Ma)
|RA971.3 .P755 2015||Unknown|
- Prokscha, Susanne, author.
- Includes bibliographical references and index.
- FOUNDING PRINCIPLES Introduction to SOPs What Is an SOP? Why Do We Have SOPs? Why Do We Follow SOPs? Beyond SOPs Say What We Do, Do What We Say Document Hierarchies Controlled Documents and Managed Documents Overview of the Hierarchy More about Controlled Document Types More about Managed Document Types Other Document Types Hard-to-Classify Documents SOP of SOPs When to Have an SOP Should It Be an SOP? When an SOP Is Not Needed Other Ways to Introduce Consistency SOP of SOPs What the SOP Should Say Who, What, When, and Where How and the Level of Detail Cover One Topic or Many Topics? Too Many or Too Few SOPs SOP of SOPs Where to Put the Output What Is a Trial Master File? Contents of a TMF The TMF Connection to SOPs Not All Documents Belong in the TMF SOP of SOPs WRITING, REVIEWING, APPROVING, AND POSTING Who Writes SOPs? Which Department Provides the Author? Selecting an Author Clinical Development's Controlled Document Group SOP of SOPs Document A Stable Process SOPs Should Not Be Theoretical Testing a Procedure When You Cannot Pilot SOP of SOPs Mapping a New Process Assemble a Team Review Regulatory Requirements List Steps or Actions in the Right Order Who Is Responsible? Who Is Involved? Identify Inputs and Outputs Be Aware of Sequence and Prerequisites Translate the Process into an SOP Stay Aligned with Any Approved Process Maps SOP of SOPs The SOP Template Document Header Purpose and Scope Definitions and Background Responsibility Procedure Document Disposition References Appendices Revision History Other Considerations SOP of SOPs SOP Review and Approval Concentric Rings of Review Best Practices for Review Approval How Long Does this Take? Reviewing Documents from Other Departments SOP of SOPs Posting: Setting Up for Success Is it Really Ready to Post? Communication Plans SOP Release Cut-Over Rules Posting SOPs SOP of SOPs MAINTAINING SOPs-- MAINTAINING COMPLIANCE Deviations from Controlled Procedures Retrospective Deviations Prospective Deviations Documenting Deviations Deviations from Supporting Documents Is It Really a Deviation? SOP of SOPs Active SOP Maintenance The Environment Changes Documents Change Initiating an Update Regular SOP Review SOP of SOPs HELPING STAFF FOLLOW SOPs Finding SOPs Controlled Document Identifiers Internal Web Pages Indexes SOP of SOPs Training on SOPs Options for Training Who Has to Train on Which SOPs? Training Periods Delta Training and Minor Releases SOP of SOPs Department-Managed Documents Founding Principles Writing, Reviewing, Approving and Posting Maintaining Compliance Helping Staff Use Department-Managed Documents The Document on Department-Managed Documents ADDITIONAL TOPICS Where to Start When the Company Is Virtual Small Companies Taking on Activities As the Company Continues to Grow SOPs During Mergers and Acquisitions At First The Transition Period Later Trial Master Files SOP on Acquisitions and Mergers? Controlled Glossaries Starting the Glossary Role Names in the Glossary Maintaining the Glossary Using Glossaries Example SOP Template Example SOP of SOPs.
- (source: Nielsen Book Data)
Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (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. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.
(source: Nielsen Book Data)
- Publication date
- Copyright date
- Title Variation
- Writing and managing Standard Operating Procedures for Good Clinical Practice
- 9781482239355 (hardcover : alk. paper)
- 1482239353 (hardcover : alk. paper)
Browse related items
Start at call number: