Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, "gray areas" that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review processes and procedures to facilitate high compliance standards.
Course Objectives:
This program will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal processes to ensure that compliance of materials is appropriately assessed, evaluated, and documented. Ensure that your company has a program in place that will ensure full understanding and communication of potential risks associated with materials and ability to mitigate risk through subtle but important modifications. Ensure a high level of compliance standards by all members of the organization.
Course Outline:
• Compliance requirements
• Submission requirements
• Prior to approval
• Direct to consumer
• Social media
• Medical affairs
• Sales training
• Review process considerations
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Departments
• Regulatory Affairs Departments
• Medical Affairs Departments
• Marketing Departments
• Program & Portfolio Management
• Commercial/Corporate Compliance Departments
Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions
LIVE : Scheduled on
29-May-2024 :01:00 PM EDT
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4 Hour Virtual Seminar on Batch Record Review and Product Release
LIVE : Scheduled on
05-June-2024 :01:00 PM EDT
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4-Hour Virtual Training: How to Respond to an FDA Investigation
LIVE : Scheduled on
26-June-2024 :01:00 PM EST
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