Course Description:

This course will cover the management of "Projects" in Pharmaceutical Research. This will cover the conduct of Clinical Trials and related support activities. The course will cover the inclusion of such topics as Risk Management, Quality Management, and Regulatory Compliance as part of Project Management.

It will include the use of Quality Assurance (QA) throughout the projects.

In this two day workshop conference you will go through the common ways to do Project Management and then go through how to introduce Quality Management,, Risk Management, and Regulatory Compliance into the Project Management steps.

We will also include some suggestions on how to manage the Project Management in certain common key situations.

Learning Objectives:

Upon completing this course participants should:

  • Understand some approaches to managing the steps in any project
  • Include Quality and Quality Management into the procedures.
  • Include a risk based approach to managing the tasks, staffs, and deliverables required for the project.
  • Include Compliance to applicable Regulations in your plans and execution
  • To investigate true root causes of problems and to evaluate and prioritize solutions
  • Problem solving methods to help you asses which is best for your situation
  • Develop successful implementation plans
  • Perform risk assessments effectively

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for people tasked with managing Clinical Trials or the development of the tools used in Clinical Trials. Developing, maintaining and/or improving. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance. The following personnel will benefit from the course:

  • Clinical Project Managers
  • Research Physicians
  • Study Monitors
  • Biostatistics Managers
  • Data Managers
  • IT Staffs
  • Financial Support professionals
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Document control specialists

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Introduction
    1. Defining Projects
    2. Defining Process, Procedures, and Products
  2. Project Management Guides
    1. Project Management Institute (PMI)
    2. Institute for Electrical and Electronic Engineers (IEEE)
    3. Others
  3. Project Management Tools
    1. Forms
    2. MS Excel
    3. MS Project
  4. Project Management of Clinical Research
    1. Studies – Phase I - IV
    2. Start, Execution, Close out
    3. Records and QA
    4. Tools
  5. Project Management of Medical Devices
    1. Submissions
    2. Technical Document
    3. Others
  1. Quality Management
    1. Quality
    2. Quality Organization
    3. CAPA
  2. Risk Management
    1. Risk Analysis
    2. Risk Mitigation
    3. Risk Communication
  3. Compliance to Regulations
    1. Regulations vs Guidelines
    2. FDA
    3. HIPAA
    4. Others
  4. Managing the Project
    1. Teams
    2. Assignment of Responsibilities
    3. Some Tips/Suggestions
  5. Review of Project Management
    1. Systems Life Cycles
    2. Quality Management
    3. Risk Management
    4. Compliance
  6. Questions

Meet Your Instructor

Richard Chamberlain, Ph.D.
President, Extended Clinical Services, LLC

Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation, Managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems.

Assisted in the development and validation of numerous computerized systems in all GxP environments.

Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and compliance to regulations.

Familiar with the various aspects of Computerized Systems and CFR 21, Part 11,FDA Guidelines for Computers, ICH-GCP, and GxPs.

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Local Attractions

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

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The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

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