This webinar will focus on how to establish an effective training program, at medical device companies, that will not only prepare you for an FDA inspection but will also enhance your overall business performance.
Why Should You Attend:
The USFDA requires that device manufacturers train their personnel. The requirement for training for medical device firms is contained in 21 CFR 820.25(b). During agency inspections, the investigator will check training records to see that your firm’s training program is adequate.
Designing an effective employee training program is a crucial building block for your overall Quality System. Being able to effectively demonstrate that you’ve hired employees with the right amount of education, background, training, and experience is only half the battle. The FDA also expects employees to stay up-to-date with internal, job-specific and quality related training for the entire length of their tenure with the company. During FDA inspections, the training system and training records can become a central area of concern if a company is not able to readily produce records that demonstrate control in this area.
Areas Covered in the Webinar:
Overview of Regulation.
Review of recent Warning Letters.
What’s expected by the FDA.
What doesn’t work and why.
What works and why.
Who Will Benefit:
Quality System Professionals
Company Training Coordinators
Operations Supervisors and Managers
Added by complianceonlinecom on November 7, 2012