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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
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HomeManufacturing (GMP)Project Management: Best Practices for Validation & Regulatory Projects

Project Management: Best Practices for Validation & Regulatory Projects

Teachers
Bruce Fieggen
Category:
Clinical Trials (GCP Training)/ Leadership & Training/ Manufacturing (GMP)/ Medical Device Training/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 Minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Project Management — we all think we know what it means, but how many of us truly understand the time-tested art and science of planning validation and regulatory projects for the life sciences industry?  In particular, validation and regulatory projects require unique planning and attention to detail.  Failure to do so can result in lost time to market, lost revenues, and costly sanctions.  In this course, you will learn to navigate common challenges faced when planning/executing regulatory and validation projects, ensuring that they are completed on time and within budget.

By attending this highly-interactive 90-minute webinar, you will learn…

  • How projects are defined, and the differences between projects and ongoing operations
  • The importance of support and follow-through to project success
  • Variations between approaches, standards, and methodologies
  • How to manage a project kick-off
  • How to set a project objective — and why it’s crucial
  • Tools to define a project scope and create a “Work Breakdown Structure”
  • How to effectively manage project schedules
  • How assumptions affect project budgets
  • … and more

Who Should Attend

WHO SHOULD ATTEND

This course will benefit anyone involved in the planning, budgeting, or execution of a pharma, device, or life sciences project — regardless of their role in the regulatory environment.  Those in whose functions are affected by the execution of regulatory projects — for example, those in Quality, Compliance, Manufacturing, and Commercial divisions — will also find it insightful.  Even those who don’t manage projects directly will gain an increased understanding of how successful projects work, why poorly planned projects fail, and how project planning affects the entire organization at every level.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Bruce Fieggen
Currently writing a Project Management novel, set in King Arthur’s time, to teach PM techniques in an entertaining way.

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Clear
Duration: 90 Minutes
On-demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing (GMP) (92)
  • Medical Device Training (63)
  • On-Demand Courses (239)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

Your Courses

About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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Contact

  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

Meet Our Instructors

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