Presentations/Abstracts
Process Mapping: A Sound Base for Clinical Research SOP Development
Abstract:
One of the most time consuming and inefficient activities in Clinical Research operations is the development of Standard Operating Procedures (SOPs). Every firm has their own approach in developing SOPs, but many have not mastered an effective and efficient way to write and update SOPs. So what is the solution? Process Mapping. Applied appropriately in a model that combines quality, regulatory considerations and business efficiencies, Process Mapping is a method of documenting a standardized process that can be easily converted into an SOP. Process Mapping exposes adjacent departments and functions to each other in an open forum, and results in a practical, useable product. This presentation will discuss how process mapping can be used as a basis for SOP development that will decrease the time needed for authoring and reviewing, breaks down “walls” between departments and functions, removes "silos" and provides a method for “simplifying” the SOP content into a large-scale visual format. Benefits and challenges of process mapping will be presented and attendees will walk away with practical steps for incorporating process mapping into their firm’s SOP development process.
Completing the actions in a CAPA Program for GxP Compliance – An influential and critical role for QA
Abstract:
Corrective and Preventative Action (CAPA) Programme activities are integral to the strength of Risk Management and Quality Systems governing and supporting GXP compliance in drug and device development. A good CAPA Programme requires comprehensive planning and strategies to ensure the adequacy of resolution and enforcement toward compliance goals. Effective CAPA Plans must include practical implementation tactics for success in facilitation of problems resolution and the design of preventative action initiatives. Well recognized and understood in the GMP and GLP arenas, CAPA in the GCP environment has become an accepted concept and more common application. QA has a major opportunity to be heavily involved and influence the correction of problems and contribute to preventative actions as a facilitator and enforcer. This presentation will discuss actions in a CAPA Programme that will support GXP compliance, with a specific emphasis on the important role of QA. Representative CAPA “Case Studies” for GMP, GLP and GCP will be presented, with respective roles and suggested actions by QA.
Building An Effective Clinical QA Unit With Internal And External Resources
Abstract:
QA and QC activities are an integral part of any clinical program and require a staff of adequate number and expertise to be effective. For a small company, the clinical quality assurance unit is likely to be understaffed or possibly even nonexistent. Large pharmaceutical companies have QA units that cycle through growth and downsizing periods. Depending on where they are in this cycle, the QA unit might be out of synch with the demands of current clinical activities. For both of these situations, QA activities can be completely outsourced. This scenario, while convenient, is not the most cost effective means of addressing QA needs over the long-term. A more effective and efficient model of a clinical QA unit is the integration of both internal and external resources. The internal component is essential for ensuring adequate management of the clinical QA program, establishing goals that meet corporate objectives, and facilitating ongoing communication with senior management. The external component is determined by the short-term needs of the company at any given time so the number and expertise of these resources can vary as needed.
Clinical Trial Master Files – Remedies to QA Observations
Abstract:
The conduct of Clinical Research studies includes extensive and detailed activities related to the collection, organization and maintenance of general study files and investigator-specific documents. Unfortunately it appears that industry-wide efforts related to both initial and ongoing quality control of individual documents as well as overall file completeness and organization remain deficient and frequently result in major findings during quality assurance audits. Too often the files for a clinical study are left as a final activity ending in crisis management clean-up, organization and collection of missing documents. What are the remedies to ensure the integrity of Clinical Trial Master Files? Our experience has shown that practical and logical planning, diligent quality control procedures and clearly defined document processing workflow will contribute to a solution. The appropriate application of new technologies for document management, including document tagging, scanning and electronic filing techniques further supports the adequate and efficient management of study files. This presentation will discuss important quality issues, study the challenges of document management, and provide suggested mechanisms and initiatives for quality management of Clinical Trial Master Files.