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HomeManufacturing (GMP)Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

Teachers
Rosanne Sylvia-Heeter
Category:
Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

In a pharmaceutical contract manufacturing arrangement, sponsor companies are only as compliant as their vendors.  When a violation occurs, the manufacturer is held responsible for the cGMP deficiency itself, while the sponsor is held responsible for its lack of vendor oversight.  The bottom line is this: If your CMO fails to meet regulatory standards, you lose out on millions in profits and patent exclusivity.  If you are a CMO, you are assured to never win business from that sponsor again.

This course will provide sponsor companies with the necessary tools to make an informed decision when qualifying a manufacturing vendor’s compliance with cGMP.  Conversely, the session will provide CMOs with proven techniques to win sponsor business and exceed regulatory AND performance expectations.

LEARNING OBJECTIVES

During this 90-minute webinar, SPONSORS will learn:

  1. The top five vendor qualification mistakes – how sponsors can avoid them
  2. The vendor selection process – weeding out dead weight in advance of the real work
  3. Establishing timelines that quickly qualify vendors for cGMP compliance

VENDORS will learn:

  1. The top five mistakes CMOs make in the qualification process
  2. How to organize and prepare for a vendor audit – right the compliance ship!
  3. Forming lasting relationships with your sponsor and ensure repeat business

Discussion will also focus on:

  1. Steps to identify needed outsourced services and begin the qualification process
  2. Inter-departmental coordination to ensure that the outsourced services meet the identified need
  3. Vendor interactions and the selection process – keys to success
  4. On-site vendor assessments – make the most of your time on-premises
  5. Resolutions/corrective action for observations
  6. Essential documentation, such as paper questionnaires, quality agreements, and vendor qualification checklists
  7. Data tracking and requalification activities

Who Should Attend

WHO SHOULD ATTEND

This course is designed for anyone interested in improving their vendor qualification process – from either the sponsor or vendor side. Those in quality assurance, business development, purchasing, research and development, and project management will find this course especially useful.

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

Rosanne Sylvia-Heeter
30+ years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.

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Clear
Duration: 90 minutes
On-demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
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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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