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

Webinar on FDA Labeling Requirements – New Regulations

 
  November 21, 2016  
     
 


Compliance Trainings, Online
2016-12-09


Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized.

The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA requires companies to submit product information documents in QRD-compliant format.

Companies in the regulated life sciences industries must develop and implement systems and processes that will ensure compliance with these standards for their global labeling content. They must also take a longer-term view as to how best to minimize the complexity and cost of doing so.

In this webinar, we will discuss ways to overcome these regulatory challenges and understand how companies in the life sciences industries are doing so through best practices.

Areas Covered in the Session :

Product labeling background and rationale

Requirements for complying with FDA and EMA requirements for labeling

Converting Word documents into XML and SPL format

The essential labeling materials that are covered

Organizing and maintaining labeling records efficiently and effectively

Inspection of labeling records

Interactive Q&A Session

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

Those responsible for designing, creating and maintaining product labels and labeling records

Manufacturing and Quality Assurance professionals responsible for labeling content, format and management

IT professionals involved in the conversion of label content formats for electronic labels

Quality Assurance Personnel

Auditors engaged in the internal inspection of labeling records and practices

 

Consultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and management

 
 
Organized by: Compliance Trainings
Invited Speakers:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

 

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

 
Deadline for Abstracts: 2016-12-09
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/product/fda-labeling-requirements-new-regulations/

E-mail: suzzane.d@compliancetrainings.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.