FDA Compliance Boot Camp 2013 Agenda



Course #1, Course #2 and Course #3 Agendas

Course #1 — FDA Auditing of Computerized Systems and Part 11/Annex 11

MONDAY

8:30 a.m.

Welcome and Introduction

FDA Inspections and Part 11 Compliance
Denise Dion

9:45 a.m.

Questions & Answers/Discussion

10:00 a.m.

Break

10:15 a.m.

FDA Inspections and Regulatory Compliance, Including Part 11 Scope, Application and Enforcement
Martin Browning

12:00 p.m.

Questions & Answers/Discussion

12:30 p.m.

Buffet Luncheon

1:30 p.m.

Annex 11 (2011 Revision): The EU’s Updated Counterpart to 21 CFR Part 11
Martin Browning

2:30 p.m.

Questions & Answers/Discussion

2:45 p.m.

Break

3:00 p.m.

Computerized Systems Development: Models and Methods
Jan Olson

5:00 p.m.

Questions & Answers/Discussion

5:30 p.m.

Adjourn Day 1

TUESDAY

8:30 a.m.

Principles of Computerized System Validation
Jan Olson

10:00 a.m.

Questions & Answers/Discussion

10:15 a.m.

Break

10:30 a.m.

Inspections of Computerized System Development and Maintenance
Denise Dion

12:15 p.m.

Questions & Answers/Discussion

12:30 p.m.

Buffet Luncheon

1:30 p.m.

Mock Audit: Inspections of Computerized System Development and Maintenance
Martin, Jan and Denise

5:30 p.m.

Adjourn Day 2

WEDNESDAY

8:30 a.m.

Mock Audit (cont’d): Inspections of Computerized System Development and Maintenance
Martin, Jan and Denise

12:30 p.m.

Buffet Luncheon

1:30 p.m.

Mock Audit (con’t): Inspections of Computerized System Development and Maintenance
Martin, Jan and Denise

3:00 p.m.

Break

3:15 p.m.

Regulatory Enforcement: Overview and Trends
Martin Browning

5:00 p.m.

Questions & Answers/Discussion

5:30 p.m.

Adjourn

Course #2 — Quality Risk Management for FDA/ICHQ9 Compliance

THURSDAY

7:30 a.m. – 8:30 a.m.

Registration; Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Definitions: Getting Proficient in the Language of Risk
    • Concepts and definitions used by FDA
    • Differences between FDA and ISO/ICH terms
    • Relationship between “use” and “risk”
  • Regulatory Foundations
    • The history of managing risks in drugs and devices
    • Current FDA rules mandating risk management
    • Latest FDA/ICH guidance and policies

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • Overview of Risk Management Approaches
    • FDA’s “3P” expectations for managing:
      • People risks
      • Product risks
      • Process risks
    • Role of risk management in compliant GxP and electronic record-keeping systems
  • Key Principals of Risk Management
    • Relationship of Severity, Likelihood and Detectability
    • Introduction to tools for risk assessment and hazard control
    • Learning which tools work best in what situations

12:30 p.m. – 1:30 p.m.

Buffet Luncheon

1:30 p.m. – 3:30 p.m.

  • Risk Management Planning
    • Methods for integrating risk management with your quality system
    • Using risk management to better understand and improve processes
    • Lifecycle risk management – why it’s critical, and when it’s required

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

  • The Risk Assessment Process
    • The ISO 14971 risk management model
    • How Six Sigma and the risk management process interact
  • The Initial Risk Evaluation:
    • Proven tools to assess, evaluate and prioritize risks:
      • Processing mapping
      • HAZOP
      • Ishikawa diagrams
      • Fault Tree
      • HACCP
      • FMEA

5:30 p.m.

Adjourn Day 1

FRIDAY

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Mitigating Risk: Preparing and Implementing a Plan
    • Understanding and accounting for residual risk
    • How to factor risk mitigations into residual risk estimates
    • The biggest mistakes companies make in implementing risk mitigations
  • Risk Management Reports and Communication
    • What factors you should document in your overall risk evaluation
    • Communicating risks: key principles and best practices
    • Identifying risk communication audiences

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • Post-Launch Reviews: Process Risk Performance and Feedback
    • Monitoring ongoing risks throughout the product’s life
    • Using quality system data to manage process risks during commercial production
    • Gathering and integrating feedback from the field
  • Course Exam (Self-Test; Open Book)

12:30 p.m.

Adjourn Class

Course #3 — The CAPA Confidence Clinic: FDA Rules for CAPA Systems, Failure Investigations and Complaint Management

THURSDAY

7:30 a.m. – 8:30 a.m.

Registration; Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Regulatory Requirements for CAPA
    • FDA’s requirements for Corrective and Preventive Action systems
    • Specific GLP, Drug GMP and Medical Device CAPA regulations
    • Why CAPA systems continue to be at the top of FDA’s enforcement list
    • Role of CAPA in meeting global rules and standards

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • Elements of Effective CAPA Systems
    • Framework for a compliant CAPA system
    • Where and how the CAPA feedback loop improves your overall quality system
    • Definitions of a correction, corrective action, and preventive action – and why the difference matters
    • How companies like yours are organizing their CAPA systems
12:30 p.m. – 1:30 p.m.

Buffet Luncheon

1:30 p.m. – 3:30 p.m.

  • CAPA Tools
    • CAPA data sources – gathering feedback from throughout your organization
    • Recommended flow chart for CAPA data collection and closure
    • Review of some commercially available CAPA management systems
    • Key points to consider in picking the right CAPA tools for your needs

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

  • What to Look for in Failure Investigations/Root Cause Analysis
    • Key objectives and phases of failure investigations
    • How to conduct a proper failure investigation to its root cause
    • OOS investigations – a special type
    • Failure Investigations Tools
      • What they are
      • How they are used
      • Reporting objectives

5:30 p.m.

Adjourn Day 1

FRIDAY

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Trending Requirements and CAPA
    • Drug and device trending requirements – what and when to trend
    • Use of statistics to find and fix CAPA problems
    • Often overlooked but critical internal and external feedback sources
    • Use of Risk (Process, Product) to determine when and if to escalate to a CAPA
10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • FDA Enforcement Priorities
    • Understanding FDA’s mindset
    • Inspection Observations and Reports
    • Consequences of non-compliance
    • Recent trends in FDA 483 observations
    • Practical suggestions surviving an inspection
  • Course Exam (Self-Test; Open Book)

12:30 p.m.

Adjourn Class