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Short Course

Course Information
Course Title: (CANCELED) Executing High Value Process Improvements during Laboratory Informatics Implementation Planning
Categories: 1 - Data Management
2 - Laboratory Information and Management
Instructor(s): Michael Barkan Course Number: 135
Affiliation: CSols, Inc.
Course Date: 03/09/2017 - Thursday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $325 ($425 after 2/18/17) Textbook Fee:

Course Description
This course will build on the course “IDENTIFYING High Value Process Improvements During Laboratory Informatics Implementation Planning”. This course will show laboratory specialists and their colleagues how to take a deep dive into the organization’s laboratory business processes and procedures to implement process improvements. The focus will be on executing previously identified high value improvements with an eye towards future automated systems. Often improvements center on eliminating paper processes, but a software system (CDS, LIMS, SDMS, ELN, LES) is half only the solution. The laboratory can realize additional value by employing improvements that fit well with planned automation and informatics deployment. This course will recommend procedural improvements to optimize laboratory processes and identify when and how to make the changes before laboratory informatics installation and validation.

Target Audience
This presentation is for individuals who have knowledge of laboratory operations, including informatics experts, senior laboratory personnel, laboratory leadership, and quality team members. Individuals in this course will be advised on where to make improvements on procedures and practices before an informatics deployment.

Course Outline
Attendance in “IDENTIFYING High Value Process Improvements During Laboratory Informatics Implementation Planning” is not necessary for this course. However, this course will not cover selection of which processes to improve, but how to improve processes that have already been selected.
If the following items are systematically optimized to align as part of an informatics project, deployment of CDS, LIMS, SDMS, ELN, or LES will be easier and more successful.
• Going from “paper to plastic”
o The value of eliminating paper-based processes
o How to transition selected high value processes from paper to automated systems
o Considerations for future laboratory informatics implementations
o Challenges to expect
• How to make process improvements in the following common pain points:
o Sample workflows
o Laboratory chemical and consumables inventory
o Resource management
o Laboratory data management and archiving
o Reporting
• Quality and regulatory considerations
o Working with your quality and regulatory departments
o General considerations and industry-specific concerns
o Challenges to expect
o Product release
o Metrics and data reporting and trending
o Investigations and CAPA
o Planning well in advance for validation
o Performing validations
• Case studies
• Laboratory changes that impact business and enterprise-level processes
o Involving non-laboratory stakeholders and process owners
o Challenges to expect
o Business- or enterprise-wide harmonization and standardization
o Standard operating procedures
o Document management
o Training practices and documentation
o Purchasing practices

Course Instructor's Biography
Mike Barkan has worked in pharmaceutical laboratories as an informatics leader for over 20 years. During his time in a pharmaceutical R&D group, he and his team members validated and deployed Empower 3 in regulated labs across the globe. Mike has extensive experience using software tools to optimize laboratory processing, including authoring countless SOPs, many validations and deployments of benchtop systems (FTIR, UV, ICP/MS, ISE electrode), and serving as the global system administrator and system business owner for Empower 3 In addition, Mike has worked extensively in LabWare 5 and LabWare 6, administered calibration management for large laboratories, and authored SOPs for Chromatography, LabWare LIMS and benchtop systems. Currently Mike is a Laboratory Informatics Consultant with CSols, Inc., the premier Laboratory Informatics consultancy in North America. Mike’s laboratory informatics projects focus on LIMS validation as well as laboratory informatics improvements, planning, and strategy.