The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used in auditing.
This course will provide guidance on best practices for conducting audits, how to conduct an internal audit A to Z, explore strategies for dealing with common internal auditing issues.
Areas Covered in the Session :
- Overview Of Internal Auditing
- What is auditing?
- What are the auditors’ responsibilities?
- Planning The Audit
- How to get started?
- Writing the audit plan
- Developing audit checklists
- What do I review before the audit?
- What are the applicable regulations & standards?
- Opening meetings
- The Audit
- Opening meeting
- Who should participate?
- Auditing techniques
- How do I find out what I need to know?
- Interviewing and gathering evidence
- Making the auditee comfortable
- Questioning techniques
- What is an observation/finding?
- How do I write my observation/findings?
- Wrapping up the audit
- The closing meeting
Who Should Attend:
- Internal Auditors Beginner
- Professionals planning to move into Internal Auditing
- New Quality Auditors
Course Director: MARIE DORAT
Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.
Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.
She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.
She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.