FDA Labeling Requirements – New Regulations

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

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. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance