Category: Management Strategies , Biotechnology , Laboratory , Pharmaceutical/Biologics , Quality , Supply Chain
Best Practices for Online Learning
(validated by the FDA)

Date: 7 February 2011
Location:  David Intercontinental Hotel, Tel-Aviv
Course Language: English
Duration: 1 - Day Course
Hours: 9:30-15:00
Registration: 9.00-9.30
Price: 480 NIS + VAT, BioForum clients – free of charge
Credit Points: 0
SKU: 11423
 

Bioforum is Proud to Launch

and invites you to participate in a one day seminar on: 


Part of the International Week of Chemistry

   About the Program

Kaplan EduNeering and BioForum are collaborating to provide the Israeli industry with the most relevant quality and compliance training practices. Kaplan EduNeering is a leader in providing online compliance training solutions with more than 200 clients in 50 countries

Kaplan’s solutions include ComplianceWire®, a web-based 21 CFR Part 11 validated Learning Management System (LMS) and about 120 online learning modules covering food, drug, device manufacturing and inspection topics. Since 1999, Kaplan has maintained a unique relationship with the FDA, under which it developed and maintains the online university to train the agency’s investigators

   Issues to be covered

  • Moving from a paper-based training process to an electronic training management approach
  • Building a role-based qualification program
  • SOP management - how to validate delivery and understand critical information
  • How to prepare for an audit (training components)
  • Addressing “hot” quality and compliance issues
  • A technology demonstration for each topic will be Presented
  • IT aspects for LMS implementation

   Who Should Attend

HR and Training Professionals, Compliance and Quality Managers and IT Specialists in the biomed industry (drugs, biologics, devices), chemistry, food and cosmetics


   Benefits to the Participants

  • Identify new trends in compliance, quality and training (including updates on recent regulatory activity) that can cost-effectively leverage the company's programs
  • Provide educational forums to promote quality and compliance programs for the life science and other industries and create educational networking opportunities
You are here…  
  …And want to be here

Training Records Stored in File Cabinets

Shift from Paper-Based to Electronic Compliance Accessible & Auditable Training Records
GMP Training Not Standardized Distribute Basic & Advanced GMP Content Sustained On–Boarding & Mastery Knowledge
SOP Training Not Effective Ensure Proper Distribution and Retention Improved Performance
& Product Quality
Key Qualifications Not Defined Align Training Matrices by Job Role Standardized Training Across Job Roles
Inefficient Audit Record Management Generate Audit-Ready Training Reports Reduce Risk and Improved Visibility

 

   Program

09:00-09:30 Registration, coffee and networking
09:30-09:45 Introduction, seminar goals, key issues and challenges
09:45-10:15 Moving from a paper-based training process to an electronic training management approach, with practical examples using the ComplianceWire®
10:15-10:45 Building a role-based qualification program
10:45-11:15 Coffee break
 11:15-11:45 Current compliance & regulatory issues with training programs
(by Karen Ginsbury, Israel)

 11:45-12:30  Preparing for an audit (training)
12:30-13:30 SOP management, how to validate delivery and understanding of critical information, with practical examples using the ComplianceWire®
13:30-14:30 Lunch break
14:30-15:00 More detailed demonstration of ComplianceWire®

Participants are invited to schedule a one-on-one meeting with Kaplan’s experts.

   About the speakers

 
Kaplan Eduneering will be represented by the following speakers:

  • Ellen Leinfuss, Senior Vice President, Life Sciences
  • Michael Stinson, Vice President, Sales
  • Paul Gould, Business Solutions Director

    Registration (mandatory)

  • Seminar fee: 480 NIS + VAT
  • BioForum clients – free of charge
  • Participation is limited to 2 representatives per company 

For further details please contact Ms. Shani Bullock at  shani@bioforumint.com
or: 054-8355052

To learn more about Kaplan EduNeering please click here www.kaplaneduneering.com

 

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