home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

Managing Standard Operating Procedures in the FDA Regulated Environment

 
  August 08, 2016  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
September 7, 2016 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This training has been designed to benefit professionals in the FDA regulated industries including pharmaceutical, medical device, biotechnology, cosmetic and food. It will be especially valuable to those Directors, Managers, Professionals, Technical writers and General staff charged with the responsibility for creating, reviewing and approving written standard operating procedures and instructions. 

Course Description
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection. In this webinar you will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow. 

This 90-minute accredited training will cover such topics as: 
• Why written procedures are beneficial 
• FDA expectations for written documents and Regulatory Requirements 
• Developing an effective review and approval process compliant with regulatory requirements
• How to implement a training program for document creation and review 
• A system for the control, archival, and disposal of written procedures

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

This course will be available On Demand: September 8, 2016
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Danielle DeLucy, MS, Independent Consultant to the Biologics and Pharmaceutical Industries

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed. 

 


 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.