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HomeManufacturing (GMP)A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management

A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management

Teachers
Jerry Chapman
Category:
Manufacturing (GMP)/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear
Duration: 90-Minutes
On-Demand
Includes handouts!
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Keeping current and compliant with global health authority manufacturing mandates is based on understanding and implementing a set of “external GMP surveillance and influence” processes to ensure a GMP manufacturing facility remains compliant with the ever-changing “C” in current Good Manufacturing Processes (cGMP).  To maximize compliance and audit success, firms must take a “holistic” approach – blending training, an understanding of health authority expectations, and the implementation of a “Quality Knowledge System.”  This interactive session will provide you will the tools to get started.

This webinar is designed to educate attendees on how to design processes that can be used to determine what human health agencies around the world are looking for from law, guidance, and technical manufacturing perspectives.  We will cover the necessary steps to ensure CGMP compliance for pharmaceutical company manufacturing , contract manufacturing organizations (CMOs), and suppliers.  A Process Model will be proposed and discussed, including when and where to find important information.  Strategies will be discussed on the appropriate communication and archive methods for the outputs from the processes.  An important part of the process is ensuring all relevant information gets to the appropriate levels of the organization, and how it can be repurposed to use as GMP training.

Importantly, the concept of Quality Knowledge Management (QKM) will be introduced, and participants will learn the value of QKM to their organizations and how to build QKM processes based on organizational needs.  QKM is not an expensive technology investment.  A robust set of processes can be built using relatively simple tools that are probably already in-house.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

  • Identify the importance of an external GMP surveillance and influence process to organization compliance
  • Design and build a GMP surveillance process
  • Package process output for individuals at different organization levels
  • Repurpose the process output to produce GMP training
  • Identify what a quality knowledge management system is, how it is used, and how it benefits the company

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to quality, manufacturing, and regulatory personnel that are subject to GMP regulations as put forth by the US FDA and EU authorities. This includes personnel in:

  • Quality
  • Manufacturing
  • Regulatory
  • Compliance
  • Other functions subject to GMP compliance

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

Jerry Chapman
Jerry Chapman is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry.

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Clear
Duration: 90-Minutes
On-Demand
Includes handouts!

CATEGORIES

  • Coronavirus / COVID-19 (4)
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