5Ws performs:
FDA Mock cGMP six system audits/inspections in:
Sterile, Solid, Liquid, Oil, Cream, Patch formulations and APIs
Pre-approval inspection preparation
Directed inspections
Deviations and OOS investigations
What you send to the FDA can be crucial
Our reviews assure that your:
FDA 483 responses
FDA warning letter responses
CAPAs
SOP
investigations
analytical methods
Other GMP related documents
Meet FDA expectations,
clearly convey the intended meaning,
and sufficiently address the issue.
Interactive courses on:
1. Integrity/GMP for the Pharmaceutical Industry
(Think like an FDA investigator)
2. OOS and Complaint Investigations
3. Aseptic techniques.
4. Overview of CGMP 210/211
Short training sessions on directed subjects
Q&A Sessions with your people
Realize Lasting Improvements
We work together with your personnel to realize lasting improvements:
Review/Discuss/Align
Training (OJT & Formal)
CAPA Tracking
Periodic Verification Audits
FDA Meeting Support
FDA Meeting/Presentation:
Mock meeting dry run
5Ws will attend FDA meetings to respond as needed
DEA Audits:
Experienced In:
Mock DEA Audit
Controlled substance security requirements
DEA Due Diligence policies
Staff Augmentation
Internal & External Specialists Availble For:
Project Management
Quality & Compliance
Audit and Remediation
CV provided
for matched experts
