Overview: This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft.
This guidance document contains several statements that make it clear that statistical procedures will be expected. Some of these procedures are of an advanced nature and companies need to be prepared to meet these requirements.
Areas Covered in the Session:
In general what topics does the new draft guidance cover?
What are the specific statements?
What are these statistical procedures, and how are we expected to apply them?
If we lack statistical expertise, what can we do to ensure compliance?
Who Will Benefit:
Personnel who will need to plan and execute process validation studies.
Supervisors who will need to review process validation reports and execute studies.
Quality assurance and control personnel.
Managers responsible for quality operations.
Auditors and others who will need to periodically review or check studies.