Accurate FDA Consultants ~ Training

ON-SITE TRAINING:

Accurate Consultants provides on-site, customized personnel and management training for the FDA regulated industry both in the United States and abroad.

Training seminars are tailored to your company’s specific needs and are interactive. We provide most seminars in English, but are also able to provide some training course in German. For example, the FDA Quality System Regulation (QSR) for Medical Devices in now available in German. Our training workbooks that are not only used in the classroom, but are seen as useful resources in an employee’s everyday working environment. For example, in the System-Based Training and Your Internal Auditing Program, we provide a comprehensive workbook that can be an important resource when developing an audit checklist for either an internal and external audit.

We provide on-site training in the following areas:

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Manufacturing
• Compliance

Medical Device Training Courses [English]:	Location
1) FDA’s Quality System Regulation (QSR)/CGMPs	[World-Wide]
2) Quality System Inspection Technique (QSIT) and Your Internal Auditing Program	[World-Wide]
3) Preparing and Managing FDA Inspections	[Europe Only]
4) Writing Effective 483 Responses and Executing Corrective Action Plans	[Europe Only]
Medical Device Training Courses [German]:
5) US Food and Drug Administrations (FDA) Quality System Regulation (QSR)/CGMPs for Medical Devices	[World-Wide]
Drug/Biologic Training Courses [English]:
6) US FDA System-Based Inspections and Your Internal Auditing Program	[Europe Only]
7) Best Practices for Writing Laboratory and Manufacturing Investigations	[World-wide]
8) Preparing and Managing FDA Inspections: Executing A Mock FDA Inspection	[Europe Only]

Contact us to discuss your training needs and requirements.

Accurate Consultants
Glen Feye, M.S., CQE
Principal Consultant