Votre événement devrait être ici ! Pour référencer, gérer, promouvoir... Pour s'informer ou se former ... Inscriptions en ligne

Langue du site : Français - English
Réf : 29051
Evènement :Medical Device Employee Training - Requirements and Implementation Tips

Date :Mercredi 27 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.

Objectives

  • Understanding FDA and ISO training requirements
  • Understanding how to manage an effective training process
  • Developing and documenting employee training needs
  • Techniques for tracking training for all sized companies
  • Understanding training effectiveness and ways to document it

Program

Areas Covered in the Webinar:

  • Types of training requirements from the FDA and ISO 13485
  • Examples of ways to document training needs for employees
  • Various ways to monitor the effectiveness of each type of training
  • Examples of simple spreadsheets that can be used to track training needs and records in one file. These are ideal for small and medium sized companies.
  • Overview of types of solutions that can be applied to larger medical device companies.
  • Specific techniques for monitoring and documenting training effectiveness

Speakers

Betty Lane

Betty Lane
Founder and President, Be Quality Associates LLC

Betty Lane, has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

Pour accéder aux informations vous devez être connecté. Créer un compte est facile et gratuit!

Connexion à votre compte
S'inscrire sur Doctorama

Précisions

Medical Device Employee Training - Requirements and Implementation Tips Management
medical device training, quality training, training needs, training effectiveness, capa, cgmp, iso 13485, continuous improvement
Professionnels, Quality Management Human Resource Managers Quality Specialists Training Supervisors Production Supervisors Quality Specialists Quality Associates Operations and Manufacturing Managers
10 -- --
English

Divers

Pour plus d'informations sur Medical Device Employee Training - Requirements and Implementation Tips, veuillez contacter ComplianceOnline

Pour afficher le site de l'annonceur, obtenir une lettre d'invitation, vous devez être connecté

Connexion à votre compte
S'inscrire sur Doctorama


Recommander cet évènement