Live Webinar:-FDA Labeling Requirements

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

Description

Join This course On, February 22, 2017,1:00 PM – 2:30 PM EST

"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.

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 should also attend if you are responsible for developing and maintaining the systems required for submitting XML labeling content in Structured Product Labeling (SPL) format.
Finally, you should attend if you are responsible for ensuring compliance with labeling requirements for your company.

Areas Covered

After this 90-minute webinar, you’ll come away with an enhanced understanding of how to:
-- 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
-- Q&A

Who will Benefit

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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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