FDA GMP Inspections – Proven Preparation & Survival Techniques

Teachers
Michael Hamrell
Category:
Manufacturing/ Regulatory & Compliance/ Upcoming Live Courses/
Clear
Duration: 90 minutes
Live Date TBD!
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

FDA requirements regarding Good Manufacturing Practices (GMP) and related inspections have been around for decades.  However, GMP deficiencies are still among the most cited reasons for regulatory action.  Often, simple proactive steps can be taken to strengthen GMP programs, resulting in compliant operations which will stand up to regulatory scrutiny.  This 90-minute course will provide you with the tools to safeguard against inspection deficiencies and satisfy regulatory agencies that your efforts are compliant.

LEARNING OBJECTIVES

By attending this course, you will learn:

  1. Tips & tricks to prepare for – and survive – a FDA GMP inspection
  2. The top five issues inspectors look for and how to avoid them
  3. Actionable steps that will allow you to be prepared for ANY contingency
  4. How to respond to inspection findings and avoid further regulatory action
  5. Communicating with the FDA – what to say, what not to say, and when to say it

Who Should Attend

WHO SHOULD ATTEND

This course will be of particular benefit to anyone involved in a manufacturing environment in the life sciences. Additionally, this course is extremely useful for both sponsor and vendor companies (e.g. Contract Manufacturing Organizations) who need an understanding of the GMP inspection process.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: Live Date TBD!
Time: 1:00 – 2:30 PM EDT

Choose to participate live or listen to the recording afterward!

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.

The recorded version of the training will be available for 30 days after purchase.

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

Michael Hamrell
Specialties include regulatory affairs, strategic development for drugs, devices and biologic products, and GMP/GLP/GCP compliance.

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