This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing. It clarifies FDA's intent using the preamble to the regulations.

Why Should You Attend:

Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.

Areas Covered in the Seminar:

• The QSR Requirements for Acceptance Activities
  • Procedures
  • Record keeping
  • Receiving
  • In-process
  • Final
  • Acceptance Status
• QSR Manual
  • Understanding the definition of a product
  • What to include in acceptance activity procedures
  • Understanding and stating acceptance criteria
  • Supplier testing as part of receiving acceptance
  • Contract laboratory testing as part of receiving inspection
  • Sampling plans and the OC curve
• Warning letters
  • Analysis of Warning Letters that cover all aspects of acceptance activities