This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.

Why Should You Attend

If you a manufacture of Medical Devices or an Importer of Medical Devices
  1. Do you know the consequences of non-compliance?
  2. Are you ready for an FDA inspection?
  3. Are you familiar with QSIT techniques?

GxP is a set of regulations and quality guidelines formulated to ensure the safety of medical devices, to maintain the quality of processes throughout the total product lifecycle. In this webinar we will examine the x-factor. We will focus on how GXP are applied in the following areas: Traceability, Accountability, and Data Integrity. The participants will learn the critical aspects of laboratory, clinical and manufacturing practice. Additionally, the potential consequences of non-compliance, and inspections.

Areas Covered in the Webinar

  • Good Laboratory Practices
  • Good Clinical Practices
  • Current Good Manufacturing Practices
  • International Conference on Harmonization (ICH)
  • Traceability
  • Accountability
  • Audit(s)
  • 483’s
  • Enforcement Discretion

Who Will Benefit:
  • Quality Assurance Professionals
  • Regulatory Professionals
  • Device Manufacturers
  • Auditors
  • Medical Device Manufacturers, Importer, Clinical Investigators, Pre-Clinical Laboratories