Auditing Basics and Fundamentals for Medical Devices and Drugs
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the accuracy, timeliness, and reliability of information.Learn how to perform these important duties and comply with the professional auditing standards. This course provides an overview of the "audit life cycle", including audit planning, conducting fieldwork, interviews, walkthroughs and tests of controls, and audit reporting and follow-up. Designed for internal auditors who are new or have limited experience in the audit profession, this short seminar will walk the participants through the basics of being an internal auditor.FDA and other worldwide health authorities all require that quality system audits take place in one form another. Audit effectiveness can be enhanced through training and the appropriate background and introduction and this course serves to help with that goal.Areas CoveredBackground Information – why are audits necessary?Auditing BasicsTraits/Skills of a Good Auditor o Toolso Potential Interview ProblemsGMP Background Information for AuditorsAudit schedulingPre-Audit InformationPre-audit preparationSchedulingConducting the AuditCommon Items to look for in an AuditAudit reporting and closeoutUnresolved issuesCourse Level - Basic/fundamental to intermediate levelsWho Should AttendManagers of the audit functionDirectors who are new to the audit functionIndividuals or departments with young, new or inexperienced personnel assigned to auditingPersonnel interested in auditingWhy Should You AttendUnderstand the quality system requirements and the role of auditingLearn and review the basics of auditingRecognize the required steps for a sound audit approachHear about the functions of hard and soft skillsDevelop a consistent approach to the lifecycle of an auditLearn about the characteristics of a good auditorDiscuss resources, standards and laws
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the accuracy, timeliness, and reliability of information.
Learn how to perform these important duties and comply with the professional auditing standards. This course provides an overview of the "audit life cycle", including audit planning, conducting fieldwork, interviews, walkthroughs and tests of controls, and audit reporting and follow-up. Designed for internal auditors who are new or have limited experience in the audit profession, this short seminar will walk the participants through the basics of being an internal auditor.
FDA and other worldwide health authorities all require that quality system audits take place in one form another. Audit effectiveness can be enhanced through training and the appropriate background and introduction and this course serves to help with that goal.
Areas Covered
- Background Information – why are audits necessary?
- Auditing Basics
- Traits/Skills of a Good Auditor
o Tools
o Potential Interview Problems - GMP Background Information for Auditors
- Audit scheduling
- Pre-Audit Information
- Pre-audit preparation
- Scheduling
- Conducting the Audit
- Common Items to look for in an Audit
- Audit reporting and closeout
- Unresolved issues
Course Level - Basic/fundamental to intermediate levels
Who Should Attend
- Managers of the audit function
- Directors who are new to the audit function
- Individuals or departments with young, new or inexperienced personnel assigned to auditing
- Personnel interested in auditing
Why Should You Attend
- Understand the quality system requirements and the role of auditing
- Learn and review the basics of auditing
- Recognize the required steps for a sound audit approach
- Hear about the functions of hard and soft skills
- Develop a consistent approach to the lifecycle of an audit
- Learn about the characteristics of a good auditor
- Discuss resources, standards and laws
