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Food science: Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP),Manufacturing,Food science,Food safety


NetZealous LLC

Summary

Price
Save 82%
£29 inc VAT (was £170)
Offer ends 31 August 2021
Study method
Online, self-paced
Duration
2 hours
Access to content
6 months
Qualification
No formal qualification
Additional info
  • Tutor is available to students
  • Certificate of completion available and is included in the price

1 student purchased this course

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Overview

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. The goal of this webinar is to enable you to:

  • Demonstrate a basic knowledge of GMP requirements
  • Interpret these requirements for your day-to-day operations
  • Avoid the negative consequences of noncompliance
  • Instill a culture of compliance in your organization


The subject of introductory GMP includes a discussion of the pivotal events that have shaped US laws on food, drugs and cosmetics; use of the terms GMP and cGMP (Current Good Manufacturing Practices); key sections in the US Code of Federal Regulations that impact drug manufacture; and how an organization can remain compliant with these regulations in their day-to-day operations.

Description

Why you should Attend:

The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market.

It is expected that all employees who are involved in pharmaceutical production will attend GMP-related training on a regular basis.

Areas Covered in the Session:

  • Food and drug oversight
  • Pivotal events that shaped laws in US and scope of FDA actions
  • GMP vs. cGMP
  • Consequences of noncompliance
  • Building a culture of compliance
  • Emphasis on education and decision-making
  • Training, memory retention, and accountability
  • Avoiding over-reliance on metrics

Who is this course for?

  • This course will be of benefit to anyone whose responsibilities fall under the umbrella of manufacturing
    Packaging or Distribution of Pharmaceutical products (e.g. Quality Assurance, Packaging, Operations, Planning)

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Study method describes the format in which the course will be delivered. At reed.co.uk courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on reed.co.uk, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.