FDA’s Training Requirements for Medical Device Manufacturers

The ineffectiveness of employee training and deficiencies the Quality Assurance program can become obvious during inspections. Ineffective training inevitably leads to problems in other QSR requirements and are used as evidence against the executive management.

Areas Covered in the Session :

Legal basis for the QSR training requirement

Training assessment and evaluation criteria

FDA inspection and evidence development

FDA discussion with management.

Who Will Benefit:

Executive management

VP of operations

VP Finance

Senior managers

Quality Assurance

Manufacturing

Engineering

Recalls

FDA QSR Consultants

Training consultants

Domestic and Foreign Manufacturers

Contract manufacturers

Contract laboratories

New employees at any level

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299