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    FDA Labeling Requirements - new regulations – across multiple FDA-regulated industries

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    Website https://www.demystifiedsolutions.com/trainingDetails/FDA-Labeling-Requirements-new-regulations-–-acr | Want to Edit it Edit Freely

    Category

    Deadline: June 28, 2017 | Date: June 28, 2017

    Venue/Country: Online

    Updated: 2017-03-10 17:15:47 (GMT+9)

    Call For Papers - CFP

    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.

    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

    Q&A

    Learning Objectives

    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.

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

    For More Info, Please Click below URL:

    https://www.demystifiedsolutions.com/trainingDetails/FDA-Labeling-Requirements-new-regulations-–-across-multiple-FDA-regulated-industries-DEMY051456


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.