Workforce Continuing Education Course Catalog

Course
Project Execution Planning (PEP) for Qualification
Name
SEF-79934
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
221816 BTEC BioNetwork Capstone Learning Center 03/05/2020 03/06/2020 K. Gibbs $270.00 20/20
Description Course Outline Requirements Intended Audience More Details
Description
A Project Execution Plan (PEP) is much more than a chart showing timescales: It is a document describing how, when and by whom a specific target or set of targets is to be achieved. These targets will include the project’s scope, timescales, costs, quality, and benefits. It will do this by showing the activities and resources required for the project. Commissioning and qualification – and subsequent validation efforts – often fail because there is no well-designed and well-documented plan to complete activities, manage deviations, and document change. An effective PEP is critical, whether for a large or small project; the methodologies are scalable to projects of all sizes and transferable to projects of all types. Learn the concepts utilized in the development of sound plans for the implementation of risk-based and lifecycle-integrated commissioning and qualification campaigns. Students will review facility design and regulatory issues in the US and Europe that reflect industry trends and changing regulatory policy, and determine best methodologies for obtaining compliance. They will build a strong foundation in C
Course Objectives
  1. Understand how facility design and regulatory compliance are closely integrated
  2. Be able to list and define GMP requirements associated with facility design
  3. Understand the regulatory viewpoint of facility design attributes
  4. Be able to summarize the qualification process
  5. Be able to summarize the facility licensing process
  6. Learn about applicable guidance documents
  7. Demonstrate the importance of proper planning for facilities qualification
  8. Become familiar with the tools, templates, and metholologies employed by the industry to commission and qualify (IQ/OQ) pharmaceutical and biotech manufacturing facilities
Outline of Instruction
  1. Introduction to facility design
  2. The role and impact of regulatory activity
  3. GMP Compliance
  4. Design and construction/installation practices
  5. Equipment and critical utility systems
  6. Good Engineering Practice
  7. Alignment of terminology and overview of integrated C&Q
    a. Project Execution Planning Overview
    b. C&Q Involvement at the Design Stage
    c. C&Q Involvement during Pre-Construction
    d. C&Q Involvement during Construction
    e. C&Q Period
  8. Performance qualification and validation
  9. Work session - Facility design
Contact Hours
16
CEU's
1.6
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information
Bionetwork Manager