Project management tools to improve productivity and compliance in Analytical laboratories: 2-day Workshop training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Project management tools to improve productivity and compliance in Analytical laboratories: 2-day Workshop  

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training seminars by ComplianceOnline ComplianceOnline   

For:

Senior Analytical managers, Quality Control/Assurance professionals, Regulatory professionals, Compliance professionals, Laboratory supervisors, Process owners, Quality auditors, Analytical Specialists

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

In this two day workshop you will learn the different tools of PM, proper mind set/expectations and sound lean lab management program skills in order to develop and implement efficient techniques. (see full course description)

 

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Training Course Syllabus:


Project management tools to improve productivity and compliance in Analytical laboratories

Course Description:

The pressure has been mounting in the pharma and biopharma industries in recent years to do more with less. Analytical laboratories are no exception to this trend. Work piles up while personnel have been cut or remain stagnant. Accelerated timelines further strain resources. Constant firefighting and band-aiding results in errors as well as compliance violations. It can be argued that the cost of non-compliance is more than that of compliance.

Often Project Management (PM) tools have been reduced to Gantt charts in many pharma and biotech companies. Applying the principles of PM can bring order, planning, predictability and overall sanity to any lab management and personnel.

In this two day workshop you will learn the different tools of PM, proper mind set/expectations and sound lean lab management program skills in order to develop and implement efficient techniques. Through case study analysis we will examine best practices to provide thoughts and ideas to develop and improve the performance of your current system. Additionally, case studies will explore how management practices of your laboratory program can help or hurt your compliance liability and the legal issues that arise from nonconformance.


Learning Objectives:

Understand the legal framework of a Customs Audit
Learn “Do’s and Don’ts” when speaking to a Customs Auditor
Identify strengths and weaknesses in your current Import/Customs Management program
Learn how to access all your import data and proactively mitigate penalties
Protect yourself and your company from escalation of culpability


Areas Covered in the Seminar:

Upon completing this course participants should be able to:

Understand what the global best PM practices are for analytical testing laboratories
Utilize a systematic risk based approach to developing an effective and scientifically justified method development, validation and technology transfer process
Evaluate effectiveness, suitability and adaptability of Gantt charts, Excel work sheets and other planning tools to increase lab efficiency
Understand the difference between research testing and development testing.
Investigate root causes of poor method performance in customer (QC) labs and to evaluate and prioritize solutions
Problem solve method issues to help assess which is best for your situation
Develop successful lab management implementation plans
Perform risk assessments effectively

Course Outline:
Day 1 (8:30 AM – 4:30 PM)


8:30 – 9:00 AM: Registration
9:00 AM: Session Start Time

Introduction to the language and tools of Project Management (PM)
Defining the problems of a modern lab
How PM tools enter into the process of lab management
The NIH syndrome. How things get done here.
The stages of drug development continuum
Recent updated agency expectations
Expected changes and resistance to change
Global harmonization and expectations
Prevention of “firefighting”
Protection of must-do activities
Managing the peaks and valleys of work load in any lab
Planning, Managing and Monitoring
Efficiency improvement studies
Qualification in-situ and initial environmental monitoring studies
Designing the program
Fundamental considerations
Policies and procedures
Risk Management as a critical tool

Day 2 (8:30 AM – 4:30 PM)


Defining the two basic focuses of Project Management Practices
Controlling the number of firefights & increasing productivity
Controlling and prioritizing compliance improvement
Initial establishment of historical trends
Establishment of a baseline lab productivity and compliance profile
Initial monitoring
Setting the goals
Trending
Risk Analysis as a tool
Setting expectations to Stakeholders
Setting internal goals and expectations
Method Transfer paradigms
Investigations
Review of FDA warning letters
Case Study Exercise from current FDA Warning Letters
Theoretical Case exercises
Questions and Answers

Seminar Summary:

In this two day workshop you will learn the different tools of PM, proper mind set/expectations and sound lean lab management program skills in order to develop and implement efficient techniques. (see full course description)

print this agenda print agenda for the Project management tools to improve productivity and compliance in Analytical laboratories: 2-day Workshop training seminar

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