FDA Compliance Boot Camp

precon

Managing & Auditing Supplier Quality: FDA Expectations, Global Standards, and Real-World Solutions

THURSDAY

7:30 a.m. – 8:30 a.m.

Registration; Continental Breakfast

8:30 a.m. – 10:30 a.m.

The Big Picture: FDA and ISO Requirements for Managing Suppliers

  • Why supplier management is a high priority at FDA
  • FDA’s regulatory authority and enforcement tools
  • Inter-relationship of ISO and FDA requirements
  • Introduction to FDA’s 7 subsystems of a compliant Quality System

Contracting with Suppliers: Establishing Expectations and Accountability

  • Three types of processes you should never hand off to a third party
  • Vendor qualification: tips for selecting suppliers who have a culture for compliance
  • How to define and document each party’s responsibilities
  • Monitoring and auditing provisions to include

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

Role of a Quality System in Managing Suppliers

  • Crucial elements your Quality System must include
  • Quality management principles under ISO
  • Definitions of key terms and concepts
  • Incorporating suppliers into your CAPA program

Integrated Auditing Techniques

  • Differences between auditing and monitoring – know which is appropriate when
  • Setting realistic goals and strategies for supplier quality audits
  • Linking the mindset of FDA inspectors with your auditing SOPs and techniques
  • Objective Evidence: recognizing the gold standard of auditing and compliance

12:30 p.m. – 1:15 p.m.

Lunch Break

1:15 p.m. – 3:30 p.m.

Tips and Requirements for Auditing Management Control

  • Management responsibility and reviews: the core of FDA’s expectations
  • What to include in your quality policies and procedures
  • Role of internal audits…and the critical importance of audit follow-up
  • Examples of FDA Warning Letters citing management control failures

Tips and Requirements for Auditing CAPAs and Non-Conformances

  • What FDA looks for in your CAPA system
  • Potential sources of CAPA information
  • Auditing non-conforming materials, complaints, and MDRs
  • Examples of FDA Warning Letters citing CAPA and root cause investigation failures

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

Tips and Requirements for Auditing Production and Process Control

  • Importance of Device Master Records and Device History Records for effective design transfer
  • FDA expectations for process control and validation
  • How responsible are you for ensuring adequate training at your suppliers?
  • Examples of FDA Warning Letters citing Process Control failures

Tips and Requirements for Auditing Records, Documents, and Change Control

  • FDA rules for electronic records and signatures
  • Expectations for validating computerized systems
  • Critical importance of audit trails
  • Examples of FDA Warning Letters citing documentation and change control failures

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.

Tips and Requirements for Auditing Facilities and Equipment Control

  • Documenting and calibrating inspection, measurement and testing equipment
  • Tools and techniques for monitoring contractor validation programs
  • Role of environmental monitoring
  • Examples of FDA Warning Letters citing Equipment Control failures

Tips and Requirements for Auditing Material Control

  • Documenting supplier status and establishing purchasing SOPs
  • Acceptance activities: ensuring incoming products meet specifications
  • Traceability: documenting units, lots and batches
  • FDA expectations for material shipping, labeling, handling and storage
  • Examples of FDA Warning Letters citing Material Control failures

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

Tips and Requirements for Auditing Design Controls

  • Differences between design verification and design validation
  • Defining and documenting essential design inputs and outputs
  • Ensuring accurate transfer of product design to production
  • Examples of FDA Warning Letters citing Design Control failures

Regulatory Enforcement: The Consequences of Non-Compliance

  • Helping your suppliers prepare for an inspection or audit
  • Can you shield your audit reports from FDA?
  • Responding to 483s and Warning Letters
  • Latest FDA enforcement priorities and targets

Course Exam (Self-Test; Open Book)

12:30 p.m.

Adjourn Class

register

Course 1 | Course 2

Back to Top