The Pharmacovigilance Audit course will help you comply with the principles and guidelines set within legislative requirements. This course will help you conduct a diagnostic overview of pharmacovigilance activities to gain a rapid understanding of the company’s current position, against the best means of practice that correspond with regulations.
This course delivers an introduction to the basics of pharmacovigilance & drug safety, including in-depth explanations of audits & inspections, as well as an explanation of how to prepare for a pharmacovigilance inspection. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge of pharmacovigilance auditing.
1. The Pharmacovigilance Audit
2. Audits & Inspections Audits vs Inspections, Types of Audits & Inspections
3. Preparing for a Pharmacovigilance Inspection
4. Audit Items
Audit Items - Collection
Audit Items - Assessment
Audit Items - Reporting
Audit Items - Analysis
Additional Audit Items
5. Company Sources of Information to be Examined
6. Pharmacovigilance Checklist
This course is designed for clinical research professionals who are faced with an authority inspection or audit. It is ideal for quality managers, project managers, clinical research professionals from biopharma and academic research organisations who have to guide their team through an EMA, FDA. MHRA or other regulatory inspection and want to know what to do before, during and after an inspection or audit.
1. Introduction and Objectives
2. Understanding GCP audit/Inspection for Regulatory Affairs and Clinical Trials and Why it is an Essential Part of Quality Assurance of Clinical Trials
• Audit vs. Inspection – similarities and differences
• The concepts of quality assurance and quality control
• GCP regulations re inspection and implications for audit
• Sharing experiences of inspections – group discussion
3. Audit/Inspection planning and checklist development for FDA, Health Canada, and EMA inspections
• Use of other information available to prepare for an audit/inspection and identify areas for attention
• Audit checklists discussion as to what is needed and review some examples of checklists and EU inspection guidelines
This section will focus on common inspection and audit areas to check. This will include reviewing FDA, Health Canada, and EMA inspection guidelines: see Eudralex 10 inspection documents and FDA Warning letters etc.
4. Understand how to manage audit and inspection meetings
• Opening and closing meetings
• What to look out for
• Consideration to areas to audit/inspection e.g.
• - training records
• - regulatory affairs activities
• - quality system
• - archives
• - computerised systems
• - SOPs etc
• Categorising your findings
Will include role play of how to manage an audit or inspection meeting. The session will go through what inspectors look for in different kinds of inspections/audits.
5. Audit/Inspection Interviews
• What sort of questions could auditors/inspectors ask? – this is to help prepare and will use real examples and sharing of experiences
6. How to respond to audit/inspection Report
• Audit reports
• Examples of audit reports
• Review of inspection reports in the public domain
7. Corrective and Preventative Action
• How to respond to inspection report findings
• Identify and find solutions to common time wasting activities in clinical research projects
• The auditor's role in monitoring responses to audit
• Using CAPA (corrective and preventative action – including the MHRA guideline covering responding to inspection findings)
Current GMP (Good Manufacturing Practice) legislation requires that there are internal and external audit programs operating as part of an integrated quality system. Effective auditing should provide evidence of operational compliance status and identify opportunities for continuous improvement and improved supply chain control and relationships. Both internal auditors and supplier auditors need to have in-depth, interactive training in audit techniques and understand how audit activities complement quality and risk management processes to ensure business compliance and identify quality improvements.
Students will learn about the key techniques and thought processes which can be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, structuring the audit, managing the audit team, classifying observations , close out and reporting, CAPAs and follow up.
Who Should Attend?
- QA auditors and trainees
- Production managers who receive internal QA and corporate GMP audits
- Engineering managers who receive internal QA and corporate GMP audits
- Production supervisors who lead Self Inspection audits
- Auditors of suppliers and contractors
Part 1: Auditing Basics
- Purpose of audits
- Justification for Quality, Compliance and Improvement
- Role Characteristics of the Auditor
- Desirable Audit Behaviours
Part 2: Auditing Types and Models
- Audit types and themes
- General model for audits
- Quality Systems - a short history
Part 3: Audit Methods, Tools and Techniques
- Basic auditing tools
- Audit methods and techniques
- Audit scheduling, planning and management
Part 4: The Audit Process
- Audit scheduling
- Conducting the audit
- Managing an audit team
Part 5: Developing an Audit Plan and Aide Memoire
- Workshop to develop audit plans and aide memoires
- Conducting the Opening Meeting: role play workshop .
Part 6: Internal Auditing and Improving the Audit System
- Organisation of the internal audit programme (Self inspections)
- Adding Value from the Audit programme
Part 7: How to Audit CAPA, OOS, OOT and QRM
- Necessity for structured investigation
- Corrective and Preventive Action procedures
- Out of Specification and Out of Trend procedures
- Risk Assessment techniques
Part 8: Auditing Products Manufacturers
- Oral solid and liquid dosage forms
- Packaging and labelling
- QC Laboratories
- Computer systems
Part 9: Classification of Observations
- Audit Reporting
- Typical observation classification schemes
- Workshop to classify a selection of typical observations
Part 10: Auditing for Approval of Suppliers/Contractors
- Technical requirements (physical properties, purity, quantity, frequency, etc)
- Critical steps and controls.
- Preferred location (UK, EU, Far East, world-wide)
- Key points of contract (Quality Technical Agreement)
Part 11: Auditing API Suppliers
- Why Audit API Manufacturers
- What is different about API operations
- Control of raw materials and process intermediates
- Manufacturing Deviations
- QC Laboratories
- Computer systems
- QP Declaration
Part 12: Data Integrity
- MHRA Guidance, FDA Guidance and Definitions
- Corporate Culture and Integrity
- Examples of Data Integrity Issues
- Types of Data Fraud
Part 13: Implications of the US-EU MRA
Part 14: Q&A, Course Review, Key Messages
- Review of the course
Good Laboratory Practice (GLP) describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA), as well as the Organization for Economic Co-operation and Development (OECD) international guidelines.
It is intended for anyone involved or planning to be involved in nonclinical laboratory studies within industry, academia, government, or other testing facilities. It provides a working knowledge of GLP that supports and reinforces technical education and training.
Provides a brief overview of the GLP course.
History of the Good Laboratory Practices: A Breach of Trust
Discusses the need for GLP regulations including the historical events that led to their initial development. It identifies how the foundations of GLPs are translated into practical controls, guidelines, and standard procedures encountered by technical and other laboratory/research personnel.
U.S. and Global Regulatory Agencies
Describes the scope and mission of the FDA, EPA, and OECD concerning nonclinical laboratory studies. It compares the typical types of study groups submitted to the FDA and EPA, and identifies the different methods used by these agencies to inspect a submitted study’s data, testing facility, and personnel for GLP compliance.
Definitions in GLP
Identifies definitions from the FDA, EPA, and OECD GLP regulations. It is intended to help learners master specific GLP terms and differentiate key terms having a similar focus among the regulations.
Components of Compliance
Explains how the foundations of GLP are observed and expressed in nonclinical laboratory settings, and in FDA’s GLP regulations. It identifies general elements of a quality system, intersecting points between key study documents that establish study control and direction, and how to evaluate and improve SOPs used in a testing facility.
GLP Requirements of Personnel
Identifies the regulatory requirements and responsibilities for personnel involved in all aspects of regulated studies including staff (technical and non-technical), study directors, management, QA personnel, and PIs.
The Responsible Use of Laboratory Animals (LA) – Part 1
Introduces the GLP regulations pertinent to the use of animals in research and testing, as well as their intersection with the Animal Welfare Act. It identifies the appropriate methods of interaction between technicians responsible for nonclinical studies and personnel responsible for tasks related to animal care and vivarium operations.
The Responsible Use of Laboratory Animals (LA) – Part 2
Identifies GLP requirements for study conduct and how they affect interactions between technical and animal care personnel. It describes the general process of an Animal and Plant Health Inspection Service (APHIS) inspection, and how to achieve regulatory compliance in end-of-study procedures such as collection of specimens, euthanasia, and necropsy.
Standard Operating Procedures (SOPs) and Equipment Operation
Identifies the importance that SOPs for common operations and equipment maintenance have on establishing a quality system. It discusses the GLP requirements for SOP preparation and differences in requirements for equipment found in research and testing facilities, and equipment that generates or measures data.
Understanding Raw Data and Reconstruction
Discusses the importance of raw data collection and analysis in nonclinical laboratory studies. It describes what constitutes raw data, the importance of raw data, how to collect and evaluate raw data, and how reconstruction of study data is accomplished to bridge gaps in a GLP-compliant manner.
Required Reading: Study Protocols
Describes the importance and role of the protocol in nonclinical laboratory studies. It discusses how the protocol is developed and used by the study director, technicians, QA personnel, and in regulatory enforcement, as well as the reasons for documentation and communication of protocol changes and deviations to all personnel involved in the study.
Archiving Study Data and Specimens
Presents the GLP requirements for a compliant study archive including the procedures that should be used to protect an archive from common hazards. It identifies the responsibilities of all personnel typically involved in archiving.
The Quality Assurance Unit (QAU)
Describes the purpose and functions of the QAU. It discusses appropriate interactions with QA professionals during study or husbandry inspections, and the requirement for QA independence from study conduct.
Chemicals, Test Articles, and Solutions
This module identifies GLP requirements for the receipt, distribution, storage, and disposal of chemicals. It describes the role of laboratory personnel in ensuring security and integrity of test and control articles, and other commonly used substances. It also discusses the proper handling procedures for commercial products and test articles by using information provided on safety data sheets (SDSs) and SOPs.
Reporting of Study Results and Regulatory Decisions on Study Disqualification
Discusses the requirements involved in creating a final report of study results intended for submission to the regulatory authorities. It identifies the conditions that may result in the disqualification of a study by FDA or EPA, and describes the role of a compliance statement in a final report. It also shows the ways in which data integrity and overall quality is directly related to the actions of study and supervisory personnel.