Course Description

LIMS: Applying the SDLC Approach to Implementation

November 2-3, 2017
New Brunswick, NJ

Course Offering 171102NJ2740
Course ID 2740

In-Person Course

Who Should Attend?
This course is intended for those individuals responsible for planning and/ or executing all or portions of the LIMS implementation strategy. The rigor of testing will be in alignment with highly regulated industries such as biotech, pharmaceuticals, and medical devices, but the strategies and approach could be applied to any industry. Potential affected departments could include:

  • QA/QC
  • Validation
  • Engineering
  • Technical Operations
  • Information Technology

Course Description
A Laboratory Information Management System (LIMS) is a valuable asset to manage the data generated daily in a laboratory. As with all validated systems, an oversight during the implementation period can be costly and slow down business processes for years to come, as well introduce unwelcomed regulatory risk. This course aims to provide participants with the tools they need to successfully implement a new LIMS platform, decommission an old system, or migrate from legacy systems.

This 2-day, intensive course will use the Good Automated Manufacturing Practices (GAMP) guidelines and a software development life cycle (SDLC) context to plan for implementation of a LIMS. Each course module will examine a phase of the SDLC, list deliverables required, and describe best practices for applying the approach. During the course, participants will workshop through their own company’s processes and LIMS platform, and come out of the course with a usable plan. A case study applying the approach to a LabWare LIMS will also be presented as a reference point.

Course Director
John Wass, CPIP, Consultant, Commissioning Agents, Inc.

John Wass is a programmatic technical Consultant and Project Manager for Commissioning Agents, Inc., a Certified Pharmaceutical Industry Professional (CPIP). Over the past decade he has participated in most stages of the product development lifecycle from concept to new market commercialization, and has implemented enterprise quality data management and manufacturing process control systems in support of these product processes. He has served as a project executive for both local, single-site and global, multi-site implementations of LabWare LIMS v6 with Pharma Template. During that time he was involved in all areas of implementation including:
  • Establishing project management controls
  • Business process definition and standardization
  • Configuration strategy
  • Validation strategy
  • Documentation and training strategy
  • System administration and configuration

Recently Mr. Wass has been engrossed in the global, multi-site development and validation of a Computerized Maintenance Management System (CMMS), which is also a common interface to a LIMS. Prior to this project he served in a technical project management role leading the technology transfer of a legacy sterile parenteral product to an international greenfield facility where a retrospective QbD approach was employed.

Venue Information
New Brunswick, NJ Area
Hotel Information sent with
course confirmation package