Module J Audits and Inspections Patricia E. Koziol 1Module J Final Version 1-May-2010.

Slides:



Advertisements
Similar presentations
Managing Compliance Related to Human Subjects Research Review Joseph Sherwin, Ph.D. Office of Regulatory Affairs University of Pennsylvania Fourth Annual.
Advertisements

1 NORTH CAROLINA COUNCIL OF INTERNAL AUDITING October 31, 2007.
Tips to a Successful Monitoring Visit
Checking & Corrective Action
The Principal Investigator’s Roles and Responsibilities Chicken Soup for the Busy Coordinator (May 2010)
HOT TOPICS ARCHIVING OR HOW NOT TO DUMP YOUR RUBBISH!
Common Mistakes & Audits 05/21/2014. Summary of audit findings by category.
Audit Ebru Mutlu-Omega CRO. General Purpose to help quality (to maintain quality at present) to assure quality (make sure that quality in future is maintained)
Clinical QA Data Audits A GCP Point of View Linda Del Paggio GCP Compliance BioBridges, LLC.
Guideline for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Clinical Trials Support Unit (CTSU) Lore Lagrone Program.
Audit of IT Systems SARQA / DKG Scandinavian Conference, October 2002, Copenhagen Sue Gregory.
© Clinical Research Practice Clinical Research Organization and Management 1.
Good Clinical Practices Regulatory Guidelines for the Conduct of Clinical research Introduction to Research Pharmacy Services Javier Palacios, R.Ph. Sponsored.
Monitoring and Auditing
Practical Effective Steps to Improve Trial QUALITY from Audit/Inspections findings Cancer Clinical Trials Unit Scotland A NCRI Accredited Cancer Trials.
Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008 GCP Compliance in our Vendors.
GCP compliance for GenISIS  This presentation is intended for clinical staff involved in recruiting patients to the GenISIS (Genetics of Influenza Susceptibility.
ROLE OF NURSES IN CLINICAL RESEARCH IN MALAWI OWEN DAIRE BSCN MPH RNM.
Quality System Overview Version Nov 2012 Alfred Medical Research & Education Precinct (AMREP) Austin Hospital © Copyright Nucleus Network 2012.
FPSC Safety, LLC ISO AUDIT.
MODULE A:MODULE A: Introduction to the CRA/CRC RolesIntroduction to the CRA/CRC Roles Jane FendlJane Fendl March 24, 2010March 24, Version: Final.
QC/QA Mary Malarkey Director, Division of Case Management Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research March.
Session 6: Data Integrity and Inspection of e-Clinical Computerized Systems May 15, 2011 | Beijing, China Kim Nitahara Principal Consultant and CEO META.
SAFETY AUDIT. 2.1 Definition of audit. Critical systematic inspection of an organization‘s activities in order to minimize losses due to accidents.
Tool Summary Sheet Note: This hidden slide will not show in a slide presentation. Remove before providing slide deck to sites. Tool: Sponsor Responsibilities.
Seafood HACCP Alliance for Training and Education Chapter 10 Principle 6: Establish Verification Procedures.
Objectives 4 Understand the ISO standards. Why are standards required? 4 Need standards to ensure that a term means the same for all 4 Need company standards.
Regulatory Overview.
Assessment of Interchangeable Multisource Medicines Quality of BE Data Dr. Henrike Potthast Training workshop: Assessment of Interchangeable.
Recapture of Day 1 Suchart Chongprasert, Ph.D. Food and Drug Administration “Practical Aspects in Performing Clinical and Bioanalytical Parts in BA/BE.
Good Clinical Practice (GCP)- An introduction Dr Noor Ibrahim Mohamed Sakian.
The Role of the Internal Auditor for Maintaining System Compliance and Promoting Continuous Improvement Wayne M. Uttke
Target Institute of Medical Education & Research (TIMER) Provides Clinical Research services to Pharmaceutical, Biotechnology product companies right.
A S Nanivadekar Introduction to GCP. A S Nanivadekar Outline Definition and scope Definition and scope Purpose of clinical research Purpose of clinical.
Building Quality Assurance into Clinical Trials. Objectives for Today: Define Quality in Research Describe How to Initiate Corrective and Preventative.
Elements of Clinical Trial Quality Assurance Regulatory Coordinator –SCTR SUCCESS Center QA Monitor – NIDA Clinical Trials Network Stephanie Gentilin,
Fourth Annual Medical Research Summit Concurrent Session 4.05 – Managing CROs and SMOs from a Compliance Perspective Michael SwiatochaAprill 23, 2004.
Planning and Surviving An Audit/Monitoring visit Carmen B. Jacobs, BS, RN,OCN, CCRP U.T. MD Anderson Cancer Center Houston, Texas U.S.A.
MODULE I Close-Out Visit/Monitoring Reports Jane Fendl April 24, Versions: Final 24-Apr-2010.
RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC) Josephine Schloesser, ACRIN Monitor Chris Steward, ACRIN QC Auditor.
Joint Research & Enterprise Office Training The team, the procedures, the monitor and the Sponsor Lucy H H Parker Clinical Research Governance Manager.
University of Miami Office of Research Compliance Assessment Lynn E. Smith, JD, CIM, CIP Johanna Stamates, RN, BA, CCRC With assistance from Elizabeth.
CLINICAL TRIALS – PHASE III. What are phase III trials  Confirmatory phase (Therapeutic confirmatory trial)  Trials are done to obtain sufficient evidence.
Quality of Bioequivalence Data Alfredo García - Arieta Training workshop: Training of BE assessors, Kiev, October 2009.
UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.
Conducting Clinical Risk Assessments And Implementing Compliance Practices Jane L. Stratton Chiron Corporation VP/Associate General Counsel Chief Compliance.
1 Overview of Fellowship Projects. Project to depend on what is available in host institution with strong mentorship Should address activities and tasks.
30/02/2008 Dept. of Pharmaceutics 1 Salient Features of Quality Assurance Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D Associate Professor Department of Pharmaceutics.
ISO DOCUMENTATION. ISO Environmental Management Systems2 Lesson Learning Goals At the end of this lesson you should be able to:  Name.
Module C FDA Regulations Regulatory Documents Patricia E. Koziol 1Module C Final Version 10-apr-2010.
RIHES-II: H ANDLING A UDITS AND I NSPECTIONS E FFECTIVE D ATE 25 D ECEMBER 2006 V ERSION : 3.0 บุญเหลือ พรึงลำภู 15 มกราคม 2557.
Office of Human Research Protection Georgia Health Sciences University.
Sponsor Visits and Monitoring
Role of Site Investigator Ensure subject safety is protected & well-managed Full compliance with requirements of Good Clinical Practice (GCP) Conduct the.
Quality & Regulatory Expectations of Outsourcing Oversight Nicky Dodsworth, VP Global Quality Assurance.
WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 9 CH 8 ISO MEASUREMENT, ANALYSIS AND IMPROVEMENT INTERNAL AUDITS.
GCP (GOOD CLINICAL PRACTISE)
Responsibilities of Sponsor, Investigator and Monitor
Quality System Deployment in a Clinical Trials Vendor Environment Jeffrey Brandt Quality Assurance Manager Rocky Mountain Poison and Drug Center First.
Issues that Matter Notification and Escalation
Good Clinical Practice (GCP) and Monitoring Practices
Responsibilities of Sponsor, Investigator and Monitor
MAINTAINING THE INVESTIGATOR’S SITE FILE
Quality Control SOP 3.12 Release Date: 08/10/2015.
Gilbert Ogetii KEMRI-Wellcome Trust Research Programme Kilifi, Kenya
Protocol Registration Manual (version 3.0, April 2015) Essential Documents Appendix (version 2.0, 20/Dec/2006)
Corrective Action Response Guidelines For TCEQ Accredited Laboratories
Quality Assurance in Clinical Trials
What is an Internal Quality Audit? What is an Internal Quality Audit?
S A Overarching SOPs Funding Secured Training Records
Presentation transcript:

Module J Audits and Inspections Patricia E. Koziol 1Module J Final Version 1-May-2010

Guideline for Good Clinical Practice Audit Purpose The purpose of a Sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions should be to evaluate trial conduct and compliance with the Protocol, SOPs, GCP and the applicable regulatory requirements. Sec Module J Final Version 1-May-2010

Selection/Qualification Auditors The Sponsor should appoint individuals who are independent of the clinical trial/data collection system(s) to conduct audits. The Sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. Sec Module J Final Version 1-May-2010

Corrective and Preventative Action (CAPA) A corrective and preventative action plan is a strategy for correcting or eliminating a nonconformance that has occurred and preventing a nonconformance from occurring in the future. Module J Final Version 1-May-20104

Feedback: Privacy Policy Feedback
Do Not Sell My Personal Information
About project: SlidePlayer Terms of Service

© 2025 SlidePlayer.com. Inc. All rights reserved.