FDA and EMA Global Labeling Challenges and Requirements 2019

Topics

• Complying with FDA and EMA requirements for labeling
• Product labeling background and rationale
• The essential labeling materials that are covered
• Converting Word documents into XML and SPL format
• Inspection of labeling records
• Organizing and maintaining labeling records efficiently and effectively

Who should Attend

• Manufacturing and Quality Assurance professionals responsible for labeling content, format and management
• Those responsible for designing, creating and maintaining product labels and labeling records
• Quality Assurance Personnel
• IT professionals involved in the conversion of label content formats for electronic labels
• Consultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and management
• Auditors engaged in the internal inspection of labeling records and practices
• All pharmaceutical, biotechnology, medical device and tobacco companies that are regulated by the FDA or an international equivalent agency