RQAP re-registration units: 2 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionThe deadline for implementation of the FDA SEND initiative is a little over a year away and many are feeling the pressure to implement and validate a SEND solution. This course will cover the process flow for harmonization, implementation and validation of a SEND solution, including the regulatory requirements covering a SEND compliant submission and potential pitfalls that may be encountered along the way. Emphasis will be placed on points to consider when meeting the expectations of SEND and workshops will allow for open discussion of issues brought forward by attendees.
ObjectivesAt the end of the course, the participants shall be able to:
- Define the regulatory requirements covering a SEND submission.
- List the elements of a compliant SEND submission.
- Identify potential pitfalls in the implementation of a SEND solution.
- Access the tools available for validation of a SEND solution.
Target AudienceAny individual who is embarking on the process of implementing and validating a SEND solution.
Agenda- 1. Introduction
- 1.a. Data processing and data integrity
- 2. Current status
- 2.a. Study types included
- 2.b. Deadlines for implementation
- 3. Regulatory expectations
- 4. What is a SEND compliant submission?
- 4.a. Required data sets
- 4.b. Standard terminology
- 4.c. Define file
- 5. Harmonization
- 5.a. Activities required to prepare for implementation of SEND
- 5.b. Data systems (electronic, paper-based, etc.)
- 6. Validation
- 6.a. Responsibilities
- 6.b. Points to Consider
- 7. Potential pitfalls
- 7.a. Risk management
- 7.b Legacy systems
- 7.c. Resource commitment
- 8. Summary
