FDA GMP Inspections – Proven Preparation & Survival Techniques

Teachers
Michael Hamrell
Category:
Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 minutes
On-Demand
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 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

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

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