Overview:
Many organizations, such as FDA, ISO, OSHA, and EPA, can conduct audits or inspections in a biotech company. Most people view these events as scary, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that, preparation is the key. We will focus on these preparatory techniques, for example, using internal auditing as a tool, developing an inspection procedure, educating employees, and conducting mock inspections. Participants will roll-play being auditors and auditees.
How You Will Benefit:
By the end of the course, participants will have gained:
- Understanding of the role of an auditor;
- Ways to prepare for an audit or inspection;
- Method for conducting a mock inspection;
- Tips on communicating with inspectors and auditors.
Course Outline:
- Introduction to FDA inspections
- Introduction to ISO audits
- Overview of other regulatory inspections
- Compare and contrast
- Preparation tools and techniques
- Communicating with inspectors/auditors
- Resources
Who Should Attend:
Anyone working in a medical device or drug company! Specifically, managers, supervisors, and personnel in customer service, purchasing, engineering, manufacturing, quality assurance, or related disciplines. Prerequisites: There are no prerequisites.
Cost:
Half-day class
Cost: $125 (includes class, all class materials, and snacks)
Instructor Bio: Linda J. Bovard, RAC
Linda J. Bovard is President of Bovard Consulting LLC. She provides regulatory consulting services to FDA-regulated companies, primarily in the medical device arena. Her services include strategic planning, pre-market submissions, labeling, training, and development, improvement, and auditing of Quality Systems. She has provided services to medical device companies for over 25 years, more than 15 years as a consultant. She has worked with entrepreneurs, virtual companies, start-ups, established small companies, and large conglomerates. Products range from sophisticated electronic devices with software to IVDs to personal use devices. Linda has a BA in Biology from Swarthmore College. She is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society and is a Certified Hazardous Materials Manager (CHMM) from the Institute of Hazardous Materials Management. She is committed to continuing education to keep up-to-date in this constantly changing field. She also passionately believes that understanding FDA is crucial for the success of regulated companies. |