JELincolnWorkshops

NEW Seminar / Workshop:

"VALIDATION PLANING -- UNDER FDA REQUIREMENTS"

For Senior Management, QA/RA, Engineering, R&D, Facility personnel, others:

o Verification and/or Validation (V&V)?

o Product: Design Input to Design Output

o Process: Mapping; HACCP

o Equipment: DQ, IQ, OQ, PQ

o Facility issues

o Software: 'In-prodict', 'As-product', process, QMS

o 11 'must-have' software validation requirements

o 21 CFR Part 11 considerations

o 'Black box' and 'white box' software V&V

o Lifecycle planning

o The Master Validation Plan

o Post-V&V activities

o Risk-based V&V

o Recent FDA findings

o Case studies

o Lab Books -- Content and Format

o Protocols -- Verifications / Validations

o V&V and the Design History File

o Root Cause / Failure Investigation / CAPA Reports

...and much more.

Includes two V&V planning projects involving a real device / case study

Also Workbook, Certificate, Breaks and Lunch provided.

Fee: $365.00 ea - single pre-registration from same company; $345.00 ea - 2nd or more from same company; $395.00 ea at the door

Date and location:

Wednesday, May 17, 2006, 8:30 A - 4:30 P (approx.)

STONEBRIDGE COUNTRY CLUB

4415 Links Dr

2400 S. Bangerter Highway

West Valley City UT 84120

Seating is limited ...

Enroll Now (first attendee):

Additional attendees from same company (same workshop):

Other Seminar / Workshop Titles:
(available off- or on-site)

o  "Regulatory Leadership Bootcamp"(TM) -- Leadership in an FDA-Regulated Company:        Team coaching;        Individual coaching also available
o  Software Validation: in-/as-product, process, system/QMS/ERP/
o  21 CFR Part 11
o  Validations:  Product, Production Equipment, Process, Molding,             Vision Systems, Clean Rooms/Hoods, Reuse of SUDs...
o  Change Control
o  Management Responsibility; Management Review
o  Design/Change Control; Design History Files (DHF)
o  Risk Management of Medical Devices (ISO 14971:2000)
o  Corrective and Preventative Action (CAPA)/Failure Investigation
o  HACCP (FDA's Hazard Analysis of Critical Control Points)
o  ISO 13485:2003 (ISO 13488, EN 46001) and  ISO 9001:2000 Familiarizatiion
o  Production and Process Control (P&PC)
o  Project/Program Management (PERT/CPM, Gantt)
o  Preparing a 510(k) Premarket Notification:  The Three Approaches
o  'Lean' Techniques in Medical Device Industry:  1) Production;         2) Product development; 3) Order taking and fulfillment.
o  6-Sigma Principles / Tools / Techniques
o  SPC (Statistical Process Control); Control Charts
o  QSIT (FDA's Quality System Inspection Technique)
o  The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820)
o  Reduced Product Cycle Time -- 'Time-to-Market' -- Reduction
o  Technical Writing for Technical Personnel (In a Regulated Industry)
o  Coaching:  Private / phone and/or group

Note: Additional or custom subjects available on request...

the majority of these workshops are facilitated by John E. Lincoln, principal consultant,

J. E. Lincoln and Associates

Medical Devices / Pharmaceuticals / Quality Systems / Regulatory Affairs / Coaching

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Last updated on 04/12/2006.