FDA Compliance Boot Camp

precon

FDA Auditing of Computerized Systems and
Part 11/Annex 11

MONDAY

8:30 a.m. – 8:45 a.m.

Welcome and Class Introductions

8:45 a.m. – 10:30 a.m.

Regulatory Framework for Computerized Systems: Introduction

10:30 a.m. 10:45 a.m.

Break

10:45 a.m. 12:15 p.m.

Part 11 and Annex 11: Analysis and Comparison of Key Requirements

12:15 p.m. 1:00 p.m.

Lunch Break

1:00 p.m. 2:30 p.m.

What Auditors Need to Know about Software Development & Computerized System Validation

2:30 p.m. 2:45 p.m.

Break

2:45 p.m. 4:30 p.m.

Planning and Executing Audits for Computerized System Validation

4:30 p.m. 5:00 p.m.

Introduction to Mock FDA Audit Scenarios

5:00 p.m.

Adjourn Day 1

TUESDAY

8:30 a.m. 9:00 a.m.

Mock FDA Audit Scenario #1: Highly Configurable System
Group Review of Documents; Preparation of Audit Questions

9:00 a.m. 10:15 a.m.

Questions & Answers/Discussion of Scenario #1

10:15 a.m. 10:30 a.m.

Break

10:30 a.m. 12:15 p.m.

Questions & Answers/Discussion of Scenario #1, continued

12:15 p.m. 1:00 p.m.

Lunch Break

1:00 p.m. 2:00 p.m.

Wrap-Up of Scenario #1: Lessons Learned and Key Take-Aways

2:00 p.m. 2:30 p.m.

Introduction to Mock FDA Audit Scenario #2:
Vendor-Hosted Learning Management System (LMS)

2:30 p.m. 2:45 p.m.

Break

2:45 p.m. 3:15 p.m.

Mock FDA Audit Scenario #2: Group Review of Documents; Preparation of Audit Questions

3:15 p.m. 5:00 p.m.

Questions & Answers/Discussion of Scenario #2

5:00 p.m.

Adjourn Day 2

WEDNESDAY

8:30 a.m. 9:30 a.m.

Wrap-Up of Scenario #2: Lessons Learned and Key Take-Aways

9:30 a.m. 10:00 a.m.

Introduction to Mock FDA Audit Scenario #3:
Hybrid In-House/Off-the-Shelf Manufacturing Execution System (MES)

10:00 a.m. 10:15 a.m.

Break

10:15 a.m. 10:45 a.m.

Mock FDA Audit Scenario #3: Group Review of Documents; Preparation of Audit Questions

10:45 a.m. 12:15 p.m.

Questions & Answers/Discussion of Scenario #3

12:15 p.m. 1:00 p.m.

Lunch Break

1:00 p.m. 2:00 p.m.

Questions & Answers/Discussion of Scenario #3, continued

2:00 p.m. 3:00 p.m.

Wrap-Up of Scenario #3: Lessons Learned and Key Take-Aways

3:00 p.m. 3:15 p.m.

Break

3:15 p.m. 4:30 p.m.

Regulatory Enforcement: Overview and Trends

4:30 p.m. 5:00 p.m.

Questions & Answers/Discussion

5:00 p.m.

Adjourn

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