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FDA GMP: Pharmaceuticals
Online Pharmaceuticals FDA-cGMP Training (21CFR210-211)($219.95)
FDA-cGMP Pharmaceuticals Training 21CFR210-211

Overview

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act . GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.

The FDA's regulations on current Good Manufacturing Practices (cGMP) affect many different phases of pharmaceutical, biologic and biopharmaceutical development .These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. Compliance occurs only if facilities strive towards a proactive management system making GMP a lifestyle shared by everyone in the organization.

Course Objective

This training course has been designed for individuals involved in manufacturing of Finished Pharmaceuticals products. It offers in-depth training on the FDA's cGMP for finished pharmaceuticals requirements. With the current regulations in US and Europe, it is critical that the pharmaceutical industry be aware of the threat and of the guidance materials available from regulatory agencies to help address pharmaceutical security concerns. Pharmaceutical security and training experts from FDA and USDA wrote and approved the course.

Course length

2-3 days (a few hours everyday) are required to complete the FDA-cGMP for Finished harmaceuticals Training

Who should attend

This track is for any individual accountable for any aspect of cGMP compliance. Anyone who do not have time to allocate a full day /days to take a LIVE class on FDA's GMP for finished pharmaceuticals, wants to quickly and efficiently understand what the pharmaceutical FDA's GMP requirements are, and implement the GMP without using a consulting firm.

Course Benefits

The course helps the cGMP practitioners in pharmaceutical industry by presenting an overview of the important concepts in a logical and natural sequence so they can begin to understand GMP regulations and begin applying them. This course concentrates on 21 CFR 211 which is for finished pharmaceutical GMPs

By participating in this 7 Step/CALISO online course, you will be able to:

  • understand and apply GMP concepts to decision making in a managerial role
  • Understand and begin implementation of the FDA guidance documents such as “The Quality Systems Approach To Pharmaceutical cGMP Regulations”, and other important FDA and ICH guidelines
  • Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
  • Know the current compliance “hot spots” that FDA and international authorities look for when inspecting for CGMP compliance
  • Know how to better locate regulatory information and interpret, assess, and make decisions concerning GMP issues

The structure of the training is as follows:

  • Sec. 210.3 Definitions
  • Part 211 - Current good manufacturing practice for finished pharmaceuticals
  • Subpart A--General Provisions
  • Subpart B--Organization and Personnel
  • Subpart C--Buildings and Facilities
  • Subpart D--Equipment
  • Subpart E--Control of Components and Drug Product Containers and Closures
  • Subpart F--Production and Process Controls
  • Subpart G--Packaging and Labeling Control
  • Subpart H--Holding and Distribution
  • Subpart J--Records and Reports
  • Subpart K--Returned and Salvaged Drug Products

Authors: CALISO Corporation

 

Required Prerequisites

This is an internet-delivered course featuring graphical presentation screens with text-based instruction, videos, and on-going quizzes to reinforce learning and retention and gauge your understanding of a topic before you move forward. Convenient and portable, this course provides instruction without the expense of travel and time away from the workplace.

  • Internet Access
  • Browser cookies enabled
  • Recent browser such as Internet Explorer, Firefox, Chrome or Safari recommended

Award of Certificate

An online training certificate will be issued upon successful completion of the course and obtaining 70% or above on the final average of the ongoing quizzes. A final Exam is provided for trainees who have less that 70%.

With your registration, you will receive online access to the course until you complete it. The limit on course completion and access to your certificate is three years.

Quantity Discounts

Quantity discounts of 15% for 10 or more students registered. The discount is automatically calculated during registration by credit card.

Course Registration

Product Code

Status

List Price

 

FDA GMP: Pharmaceuticals

In Stock

$219.95



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FAQs and Course Technical Assistance

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