cGMP Compliance – Understanding The Top Drug Enforcement Trends

Teachers
Joanna Gallant
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90-Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Compliance with Good Manufacturing Practices (GMP) is a constant source of energy, cost, and stress for pharmaceutical and biopharmaceutical manufacturers, and staying abreast of ever-changing regulations can be a struggle.  Plus, as regulators are sharing information and harmonizing approaches, existing data suggests common areas of issues being found by multiple inspectorates.

LEARNING OBJECTIVES

Join us for this 90-minute presentation where you will learn the latest cGMP compliance trends, including:

  • Most frequently cited regulatory observations – and the trends for those observations in both US and EU inspections
  • Why these issues are often cited
  • Areas of interest to be prepared for – the changes to the landscape that will affect/drive inspections in the future
  • How to identify areas of risk/concern in your own operation before the regulators do – steps you can take to avoid noncompliance

Some areas of increased inspectorate scrutiny include:

  • Data Integrity
  • Supplier Quality Agreements
  • Quality Metrics
  • And more!

Who Should Attend

WHO SHOULD ATTEND

This course will benefit anyone working in a GMP regulated environment on both a global or domestic scale, including quality, validation, regulatory, and all management personnel from sponsors and contract manufacturers (CMO) alike. Additionally, those who need to be able to communicate with manufacturing personnel will find this course extremely beneficial.

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 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Joanna Gallant
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.

There are no reviews yet.

Be the first to review “cGMP Compliance – Understanding The Top Drug Enforcement Trends”