GMP Fundamentals Bundle Series - Limited Offer

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ISPE’s On Demand training includes recorded conference sessions, instructional lead courses, webinars and e-learning modules to help you expand your skills and knowledge from the comfort of your desk.

GMP Fundamentals: Eleven-Part Bundle Series

GMP Fundamentals: Eleven-Part Bundle Series

Obtain a 10% Savings by Purchasing All Eleven Courses

ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more.

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GMP Fundamentals: Organization and Personnel

GMP Fundamentals: Organization and Personnel

The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the...
GMP Fundamentals: Packaging & Labeling Control

GMP Fundamentals: Packaging & Labeling Control

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of...
GMP Fundamentals: Organization and Personnel

GMP Fundamentals: Production & Process Controls

This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA...
GMP Fundamentals: Quality System

GMP Fundamentals: Quality System

To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work...
GMP Fundamentals: Records and Reports

GMP Fundamentals: Records and Reports

In this course, you will learn the various types of documentation and record-keeping practices used in the pharmaceutical industry, and how to establish and maintain clear policies and procedures to ensure compliance with regulatory requirements, and maintain product quality and patient safety...
GMP Refresher

GMP Refresher

Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide...
Implementation of ICH Q12 Guideline

Implementation of ICH Q12 Guideline

Delivery Mode: Webinar ISPE Team Assists Training Health Canada with Implementation of ICH Q12 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Regulatory Background International Council for Harmonisation’s (ICH) guideline entitled, “Technical and...
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On Demand Biopharmaceutical Three-Part Bundle Series

$775 Savings by Purchasing All Three Courses Overview ISPE is presenting a three-part series that will focus on an introduction to Large Molecules and the Chemistry, Manufacturing, and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small...
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Produtos Biofarmacêuticos: Aspectos CMC

Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Treinamento sobre Aspectos CMC Visão geral Este webinar é uma gravação do novo curso de instrutor, que é um curso de nível avançado sobre aspectos de Química, Fabricação e Controle (CMC) do desenvolvimento biofarmacêutico. O objetivo...