Medical Device Quality & Compliance Institute 2013 Agenda



Course #1 and Course #2 Agendas

Course #1 — QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality Systems Regulation

TUESDAY

7:30 a.m. – 8:30 a.m.

Registration; Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • FDA's Evolving Approach to Quality Systems
    • Scientific foundations of quality systems
    • Key quality system elements according to ISO and FDA
    • Speaking the lingo: important cGMP terms and definitions
  • Introduction to FDA's Quality Rules for Medical Devices
    • Core principles
    • Quality and compliance: two sides of the same coin
    • Seven FDA-recognized subsystems of your quality system
  • ISO/ICH Approaches to Quality Systems
    • Comparison of international standards to FDA expectations
    • ISO 9001: 2000 quality system requirements
    • Relationship to ISO 13485: 2003

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • QSR Management Review and Control (Subpart B)
    • Management and executive responsibilities
    • Developing a Quality Policy
    • Allocating adequate resources
  • QSR Design Control/System Development (Subpart C)
    • Tools for design control
    • Research vs. design
    • Design verification and validations
  • QSR Production and Process Controls (Subparts G, O)
    • Tools for controlling and monitoring processes
    • Process validation
    • Computerized system validation, including validating off-the-shelf software

12:30 p.m. – 1:30 p.m.

Buffet Luncheon

1:30 p.m. – 3:30 p.m.

  • QSR Corrective and Preventive Actions - CAPA (Subparts J, I, N)
    • Difference between correction vs. corrective action
    • Examples of preventive action
    • Evaluating CAPA sources
  • The Yin/Yang of Design/CAPA
    • FDA’s trending requirement
    • ISO 9001:2000 trending requirement

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

  • Laboratory Controls for combination products (21 CFR Part 211 Subpart I)
    • Process tasks for laboratory controls
    • Documenting laboratory operations
    • Validating laboratory test methods
  • Conducting Failure Investigations
    • Importance of identifying root cause
    • Seven basic investigation tools your should know
    • Best practices for reducing failures

5:30 p.m.

Adjourn Day 1

WEDNESDAY

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • QSR Documents, Records and Change control (Subparts D, M)
    • Assuring changes are reviewed and approved
    • Tools for change control
  • QSR Facility and Equipment Controls (Portions of Subpart G)
    • Minimizing adverse impacts of manufacturing environment
    • Tools for facility and equipment control
    • Key environment controls
  • QSR Material Controls (Subparts E, F, H, K, L)
    • Evaluating suppliers, contractors and consultants
    • Tools for material controls

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • How to Prepare for an FDA QSR Inspection
    • Understanding FDA’s Quality System Inspection Technique (QSIT)
    • Quality system objective evidence the inspector will want to see
    • Examples of systems-based questions to use to prepare
  • 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

Course #2 — Design Control for Medical Devices: Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing

WEDNESDAY

12:30 p.m. – 1:30 p.m.

Registration

1:30 p.m. – 3:30 p.m.

  • Introduction
  • Why Does FDA Require Design Controls?
    • FDA’s major areas of concern
    • CDRH’s cradle-to-grave vision: The Total Product Life Cycle
    • Design control as part of the Quality System Regulation (QSR)
    • FDA’s definition of key design terminology
  • FDA Guidance for Design Control
    • Defining a “substantially equivalent” production unit
    • Understanding difference between a deviation vs. nonconformance
    • Understanding difference between project design vs. product design
    • How international standards relate to FDA’s expectations

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

  • Design and Development Planning – 21 CFR 820.30 (b)
    • Implementing top-level design control procedures
    • Elements of the General Development (GDP)
    • Best practices in design planning
  • Design Review – 21 CFR 820.30 (e)
    • Types of review
    • Proven design review methods

5:30 p.m.

Adjourn Day 1

THURSDAY

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Design Input – 21 CFR 820.30 (c)
    • Understanding inputs vs. outputs
    • Typical input documents
    • Using FDA recognized standards and guidance
    • Important of Human Factor considerations
    • Good and bad examples of requirements
  • Design Output– 21 CFR 820.30 (d)
    • Process controls outputs
    • Other final output documents
    • Conducting design output review

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • Design Verification– 21 CFR 820.30 (f)
    • Verification documents
    • Understanding difference between verification vs. validation
    • Elements of a test protocol
    • What FDA looks for in test reports
    • What if the design fails V&V?
  • Design Validation– 21 CFR 820.30 (g)
    • How FDA defines validation
    • Key validation documents and methods
    • Conducting design validation review

12:30 p.m. – 1:30 p.m.

Buffet Luncheon

1:30 p.m. – 3:30 p.m.

  • Design Change – 21 CFR 820.30 (i)
    • Developing a change control policy
    • Role of planned, temporary changes
    • Identifying all areas impacted by change
    • Conducting re-verification and re-validation
  • Design Transfer to Manufacturing– 21 CFR 820.30 (h)
    • Integrating manufacturing considerations into design
    • Key design transfer documents
    • Developing a manufacturing/transfer plan
    • Proven design transfer methods

3:30 p.m. – 3:45 p.m.

Break

3:45 p.m. – 5:30 p.m.

  • Lessons learned in Design Transfer
    • Documentation reminders
    • Impacts on tooling and components
    • Conducting design transfer review
    • Importance of process control review

5:30 p.m.

Adjourn Day 2

FRIDAY

7:30 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:30 a.m.

  • Design History File (DHFs) – 21 CFR 820.30 (j)
    • FDA requirements for design history
    • Responsibilities of team leaders
    • Relationship between the DHF and the Device Master Record (DMR)
    • Creating a traceable DHF index

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:30 p.m.

  • FDA Enforcement Trends and Initiatives in Design Control
    • Review of relevant recent Warning Letters
    • Trends in enforcement penalties
    • Practical suggestions maintaining compliance
  • Course Exam (Self-Test; Open Book)

12:30 p.m.

Adjourn Class