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Establishing Effective Employee Training Programs for Medical Device Companies: What Works and What Doesn’t

  November 08, 2012  
ComplianceOnline, Online Event

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.

This webinar will focus on how to establish an effective training program that will not only prepare you for an FDA inspection but will also enhance your overall business performance.

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.
  • FDA readiness.
  • Business efficiency

Who Will Benefit:

  • Quality System Professionals
  • Quality Assurance
  • Company Training Coordinators
  • Operations Supervisors and Managers
  • Human Resources
  • Quality Auditors
Organized by: Complianceonline
Invited Speakers: Melita Ball, held Corporate Director-level leadership positions in Quality and Regulatory Compliance for Medical Device and Diagnostic companies for 17 years before she opened her consulting firm in 2006. Since then, MBC & Affiliates, LLC has grown from a one person independent consultant to a successful Life Sciences consulting firm with a team of highly qualified consultants ready to help clients tackle the most challenging compliance issues facing Medical Device and Diagnostic companies today.
Deadline for Abstracts: 2012-11-27
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702543?channel=hummolgen
E-mail: referral@complianceonline.com
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