Best Practices for Meeting the Challenges of New FDA and EU Labeling Requirements

Key Take Away

In this FDA compliance webinar, we will discuss ways to overcome the regulatory challenges based on the new requirements from FDA and EMA regulations.

Overview

Attendees will understand how companies in the life sciences industries are overcoming regulatory challenges through best practices, and in a way that reduces cost while maximizing compliance.

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.

why should you attend

You should attend this webinar if – 

• You are responsible for designing, creating or implementing product labels, or maintaining labeling records.
• You are responsible for developing and maintaining the systems required for submitting XML labeling content in Structured Product Labeling (SPL) format.  
• You are responsible for ensuring compliance with labeling requirements for your company.

Areas Covered in this Webinar

• 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

Learning Objectives

• Learn what product labeling material is subject to FDA and EMA regulation
• Understand the specifics of FDA and EMA regulations for product labeling and how to comply
• Learn how to establish and maintain a well-organized system for product labeling, and provide quality assurance for the data included
• Learn the importance of developing a consistent system for locating labeling records, and preparing them for regulatory inspection
• Learn about best practices and industry standards

Who Will Benefit

Professionals in the following industries:

• Pharmaceutical
• Medical Diagnostics
• Biotechnology
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)

Professionals in the following subject areas:

• Information technology managers and analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers
• Lab managers and staff
• Automation analysts
• Manufacturing managers and professionals
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
• Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

Speakers Profile

Carolyn Troiano

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.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Others Details

This FDA compliance webinar will discuss ways to overcome the regulatory challenges based on the new requirements from FDA and EMA regulations. Book now! For more details and updates please visit webinar website