Simplifying Global Compliance
Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript
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Conducting an Internal Audit for Pharmaceutical and Medical Device Companies
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant.
Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes.
Join Susan Schniepp — a fellow at Regulatory Compliance Associates, Inc. — for an introduction… and refresher… to conducting internal audits. She’ll describe the fundamentals and critical elements for conducting an internal audit.
After this 61-minute session you’ll understand:
- Regulatory requirements for internal auditing
- Benefits of the internal audit system
- Elements of the internal audit system
- Conducting the internal audit
- Audit reporting
- Corrective actions and next steps
Order today and learn how to perform an effective internal audit that ensures your company remains compliant.
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Pharma and Medical device manufacturing
- Auditing and compliance officers
- QA/QC managers and directors
- Production managers
- Production supervisors
- Process development staff
- Training managers
- Regulatory affairs professionals
- Executive management
- General/corporate counsel
- Personnel new to the industry
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She is a member of the PDA Board of Directors, and has served as PDA/FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs/Quality Advisory Board. Sue was awarded PDA’s Distinguished Service Award in 2008.
