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 |
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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 AttendYou should attend this webinar if you are responsible for designing, creating or implementing product labels, or maintaining labeling records.Areas Covered in this WebinarProduct labeling background and rationaleRequirements for complying with FDA and EMA requirements for labelingConverting Word documents into XML and SPL formatThe essential labeling materials that are coveredOrganizing and maintaining labeling records efficiently and effectivelyInspection of labeling recordsQ&ALearning ObjectivesYou 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 BenefitThose responsible for designing, creating and maintaining product labels and labeling recordsManufacturing and Quality Assurance professionals responsible for labeling content, format and managementIT professionals involved in the conversion of label content formats for electronic labelsQuality Assurance PersonnelAuditors engaged in the internal inspection of labeling records and practicesConsultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and managementFor More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/FDA-Labeling-Requirements-new-regulations-–-across-multiple-FDA-regulated-industries-DEMY051456
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