Seats are limited. Registration closes as soon as capacity is reached.
KENX VIRTUAL TRAINING · HALF DAY · LIVE ONLINE
Inspection Ready: Fixing the GMP Gaps That Lead to 483s
Three and a half hours with industry quality leaders on the investigation, computerized system, and change control gaps that keep turning into inspection findings, and how to close them before an investigator finds them.
Tuesday, December 2, 2026. 12:00 to 3:30 PM EST. $325 early bird through November 20 · $395 after
Bringing your team? Up to 8 seats for $1,495. Larger groups, contact info@kenx.org.
Why this training, and why now
The same gaps keep showing up on 483s year after year. Investigations close without a real root cause. Validated systems fall apart when an inspector pulls the audit trail. Changes go through without an impact assessment that would survive review. None of these are new problems, and that is exactly why investigators keep finding them.
INVESTIGATIONS
21 CFR 211.192 is consistently among the most cited drug GMP observations. “Root cause not identified” is rarely accepted as a conclusion.
COMPUTERIZED SYSTEMS
Audit trails, access controls, and data integrity remain a primary focus when inspectors review validated systems.
CHANGE CONTROL
Weak impact assessments and changes made without adequate review are recurring themes in 483s, especially when they touch validated processes or systems.
The three modules
MODULE ONE
12:05 to 12:55 PM EST
Investigations That Hold Up
Why “root cause not identified” keeps appearing in 483s, how to scope an investigation so it reaches a defensible root cause, and how to link that root cause to a CAPA that actually holds.
MODULE TWO
1:05 to 1:55 PM EST
Surviving an Audit of Your Validated Computerized Systems
What inspectors look at first in a validated system, the audit trail, access control, and data integrity expectations behind it, and how to keep your validation evidence inspection ready between audits.
MODULE THREE
2:05 to 2:55 PM EST
Inspection-Proof Change Control
Why well-intended changes still end up on 483s, the change control failure modes inspectors find most often, what “risk-based” really means to a reviewer, and how to build impact assessments that hold up.
LIVE Q&A
2:55 to 3:30 PM EST
Open Q&A
Bring the finding your site is worried about. Submit questions in advance at registration and we will work through as many as time allows.
What you leave with
01Investigation report checklist for closing with a defensible root cause
02Root cause to CAPA linkage worksheet
03Computerized system audit readiness checklist
04Change control impact assessment template
05Inspection question set covering all three areas
06Full recording of the session
Who should be in the room
QA and compliance leaders
Investigation, deviation, and CAPA owners
Validation, CSV, and CSA professionals
Manufacturing and laboratory quality teams
Data integrity and GxP IT roles
Sites preparing for a pre-approval or surveillance inspection
Registration
INDIVIDUAL
$325 early bird
Through December 2. $395 after.
One seat. Includes live access, the full toolkit, and the session recording.
TEAM
$1,495
Up to 8 seats for your team, each with live access, the toolkit, and the recording. Larger group rates are available.
No refunds are issued. With at least seven days’ notice, your registration can be transferred to a colleague or applied to a future KENX event.
Common questions
Is this a certification?
No. This is standalone training. There is no exam or credential.
Will the session be recorded?
Yes. Every registered attendee receives the recording, so you can revisit it or catch anything you missed.
How is this different from GMP University?
GMP University is a two-day conference built around peer exchange. This is a focused, taught half day with a practical toolkit, designed so your whole team can attend without travel.
Can I register my whole team?
Yes. The team rate covers up to 8 seats for $1,495. For larger groups, email info@kenx.org.
Close the gaps before an investigator finds them.
Tuesday, December 2, 2026 · 12:00 to 3:30 PM EST · Live online
