Training Solutions

Training Solutions

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

Our Training solutions are tailored to your company’s specific needs. We can provide on-site interactive training in the following areas:

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

Medical Device/IVD Training Courses

  1. Quality System Regulation (QSR)/CGMPs for Medical Devices
  2. Quality System Inspection Technique (QSIT) and Your Internal
    Auditing Program
  3. Preparing and Managing FDA Inspections
  4. Writing Effective 483 Responses and Executing Corrective
    Action Plans
  5. Design Controls

Biologic/Pharma Training Courses

  1. 6) FDA System-Based Inspections For Drug Manufacturers and
  2. Your Internal Auditing Program
  3. FDA System-Based Inspections and Your Internal Auditing Program
  4. Handling Out-of-Specification (OOS) Investigation and Properly Documenting Laboratory Investigation Reports
  5. Managing cGMP Formal Failure Investigations and the Closed Loop CAPA System
  6. Pre-Approval Inspection (PAI) Preparedness

Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of your training needs and requirements.