RQAP re-registration units: 2 GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionThis interactive workshop will provide experienced GCP QA professionals with additional skills and techniques to expand their knowledge and implementation of important new topics and trends in the QA field. This session has been designed to provide best practices and audience participation activities in employing effective interview techniques, preparing for upcoming Device GCP changes in the EU, understanding the MDSAP program and upcoming organizational and outreach efforts by US FDA. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.
ObjectivesAt the end of the course, the participants shall be able to:
- Apply more effective interview techniques during audits
- Describe important upcoming changes to Device GCPs in the EU
- Discuss pros and cons of the MDSAP program
- Explain FDA re-organization and outreach efforts (FDA Rep to be invited)
Target AudienceGCP professionals with 2 or more years of experience.
Agenda- Overview of Quality Management in Clinical Trials E6(R2) focus
- Understanding the MDSAP program
- Preparing for EU Regulatory Device GCP changes
- Employing Effective Interview Techniques When Auditing
- FDA Re-organization and Outreach Activities Update
