Association of

Laboratory Managers

This workshop is designed for those who either perform laboratory work or manage a laboratory that requires compliance with regulatory or quality system requirements. The course provides a broad overview of quality, standards, and compliance regulations in the laboratory, as well as a review of the laboratory system components that support compliance with quality system regulations as well as science based laboratory management.

Key topics include:

• Similarities and differences between cGMP, GLP, TQM, ISO 9001:2000, and Six Sigma quality.
• Successfully managing a quality system within an analytical laboratory environment.
• Laboratory organization, personnel, and analyst training and certification requirements.
• Laboratory certification and accreditation (ISO 17025).
• Calibration, qualification, and maintenance of laboratory equipment. Review of facility requirements.
• Laboratory deviations, failure investigations, and compliance with OOS requirements.
• Test method development, system suitability, and method verification and validation.
• Laboratory documentation, SOPs, project planning, reporting, record keeping, and management.
• Change control requirements for the laboratory and control systems for implementing change.
• Specification setting and sampling plans.
• Control of laboratory and reference standards
• Overview of good laboratory practices for testing facility operations.
• Preparation and requirements for audits and laboratory inspections.
• Stability testing and product evaluations ⇑

This interactive workshop aims to bridge gaps between analytical laboratories of multi-site companies, between QC and R&D labs, and between the laboratory and regulatory authorities. The workshop is oriented towards analytical lab managers that want to have a “first-time-right” start in handling company wide harmonization of analytical methods, procedures and processes leading to time and cost-savings. Key topics here are harmonization of procedures for Method Development, Method Validation and Method Transfer. Important for the interface with the regulatory authorities (both from a GxP and business perspective) are a suitable, effective quality level (at acceptable costs) incorporating the application of modern concepts like Process Analytical Technology, Risk Based Approach, and Less Paper Lab (regulated electronic archiving).

Upon completion of the workshop, you will be able to:

• Develop, describe and validate methods in such a way that they are applicable in various analytical laboratories of your multi-site company.
• Transfer analytical methods efficiently and effectively, also from R&D to QC labs.
• Identify efficiency improvements in procurement processes for the Analytical Lab.
• Identify the key aspects for implementing Risk-Based Approaches, PAT and “paperless” labs.
• Recognise pitfalls within the global harmonisation process. ⇑

This one-day workshop takes a strategic view of the laboratory system in the context of current quality philosophies to determine options for achieving best management practices. Experiences will be shared to provide insight into the obstacles and expected outcomes for the various management approaches. The workshop is designed for current managers who are seeking innovative ways to improve their leadership skills to develop closer connections with the business or for chemists aspiring to laboratory management.

Key topics include:

• Introduction / Overview
• The Lab Manager’s Job
• Leadership
• Communications
• Establish Culture
• Establish Vision
• Mentoring and Staff Development
• Management Style and Philosophies
• Creating Systems
• Operational Quality Measures
• Staying Competitive
• Managing Staff Performance
• Organizing for Performance
• Creating a Safe Workplace
• Open Discussion

You will learn how laboratories are applying current management philosophies to get closer to the business and to streamline operations. Practical details of laboratory management such as leadership styles, managing performance, teams, communication, and so forth will be discussed with emphasis on systematic approaches and helpful tools. Workshop participants are expected to share their experiences and best practices. ⇑

What constitutes “authentic leadership” in the lab of the 21st century. Where are you most effective; where do you need support? We’ll use an assessment tool, the DiSC®, to help you identify your personal style. The goal of DiSC® is to give you personal information that will help to ensure your improvement and success as a leader. You will develop an awareness of your personal leadership profile and capabilities as you develop your leadership style.

Specific activities and topics:

• Understand what authentic leadership is
• Value the necessity for different leadership styles today
• Expand your personal leadership capabilities
• Complete a validated personal profile, the DiSC® system. With DiSC® you will:
• • Understand what your personal leadership tendencies are, and access your untapped leadership potential
  • Expand your leadership palette and learn what you need to do to become more effective
  • See how you influence others, and how you might improve your personal power
  • Grasp what you do under pressure and learn how to change some of those base instincts
  • Identify the personal behaviors that are holding you back
• Develop confidence in your leadership style and capabilities
• More effectively lead the innovative team
• Become a better, more transformational, leader ⇑

This one-day workshop examines techniques and strategies for managing the quality of laboratory operations and testing in a manner that inspires customer confidence. Participants will share their experiences with various quality programs to identify best practice techniques and the situations where they are most applicable. The workshop is designed for current managers who are seeking innovative ways to improve their laboratory’s quality system and for chemists aspiring to laboratory management.

Key topics include:

• Overview of Lab Quality System
• The Laboratory Quality Manual
• The Tools of Quality
• Statistical Process Control
• Method /Instrument Validation
• Calibration
• Sampling
• Data Management
• Staff Competence and Training
• Quality Measures and Controls
• Management of Change
• Non-Conformance and Corrective/Preventive Action
• Managing Customer Satisfaction
• The Lab’s Quality Image
• Open Discussion

You will learn how laboratories are applying international standards and statistical techniques to manage the quality of their services. The intent is to view quality from a holistic point of view to gain an appreciation for how the pieces of the entire management system interact to protect the integrity of the lab’s output. Workshop participants are expected to share their experiences and best practices. ⇑

How do you hire people? How do you fire people? In this workshop we will cover these processes from beginning to end. The staffing process includes the acquisition, selection, and placement of employees to achieve the strategic human resource goals of your company. While this may seem academic, you need to accomplish these tasks on a periodic basis. One significant error will cost you time and money.

This workshop will cover the process from beginning to end. We will:

• Define job duties and write job descriptions (yes, we will actually write job descriptions on the spot, and during the workshop we will accomplish the tasks listed below)
• Assess the position and job description to develop effective recruiting ads and sources for applicants
• Learn how to screen resumes
• Identify factors that will lead to successful workers
• Write job related questions
• Interview candidates for the job
• Learn how to do reference checking so that you can get good job related information about the candidate
• Make selection decisions
• Prepare letters of acceptance and rejection
• Identify candidates for promotions, transfers, demotions, and terminations

Participants are asked (if possible) to bring the job description for their job, as well as for jobs that report to them. ⇑