(0 Item)

Effective Training for FDA Compliance What to train - How much to Train - How to Document Effectiveness

Seminar / Training - Effective Training for FDA Compliance What to train - How much to Train - How to Document Effectiveness
Seminar / Training

By : Compliance Online

Date : 2012

Location : California / Palo Alto

Video 01h 23m
Description :

In this training you will learn what are the FDA requirements for training, how to develop an effective training program, training plan for individual employees, documentation, assessment, training tools available and specific training requirements for GXP and part 11.

Keywords :

FDA requirements, GxP training, FDA, Part 11

Product/ documentation details
Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness- Webinar

Product Type : On Demand Webinar

Author : Dr. Ludwig Huber

Video 01h 23m

Languages : English

 
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors. This seminar will give a good understanding of FDA requirements for training and provide recommendations for implementation.
 
 
Hand-outs:
 
For easy implementation, attendees will receive
Primer: Successful compliance training (20 pages)
SOP: Training for GMP Compliance
SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
Who Will Benefit:
 
Pharmaceutical and medical device industry
Manufacturers of pharmaceutical ingredients
Training departments
A managers and personnel
Analysts and lab managers
Validation specialists
Regulatory affairs
Human resources (HR) managers and staff
Documentation department
Consultants
 
Note: These complimentary hand-outs will be sent to customers on request. Please email support@conferensum.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

 

Areas Covered in the Seminar:
 
GxP training requirements in US and EU.
Most frequently cited deviations.
Developing an effective training program for a company, site or department.
Developing a training plan for individual employees.
Who can or should be responsible for the training program and training plans.
Most efficient training tools for different tasks.
Assessment of successful participation.
The benefits of risk based training.
Documentation of trainings for the FDA.
Specific training requirements for Part 11.

 

Instructor Profile:
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor o Lab Compliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .
Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness- Webinar

Product Type : On Demand Webinar

Author : Dr. Ludwig Huber

Video 01h 23m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria