web analytics

Skillpad Releases new GMP e-Learning Modules for the Nutraceutical Sector
NGI-800-01 / NGI-801-01“ While you provided some written procedures for quality control operations, your warehouse manager stated that your firm has not been following such procedures…”
–  Extract from FDA Warning Letter to dietary supplement manufacturer, April 2013.As the above extract shows, if you are involved in the manufacture of products such as dietary supplements, you will need to satisfy authorities such as FDA that you have proper quality systems in place and that your personnel are trained to implement them!For the past 15 years Skillpad has been helping FDA-regulated companies to meet their training needs and is excited to announce the release of 2 new additions to its extensive library of e-Learning courseware.The new e-lessons GMP – SOPs in Nutraceutical Manufacturing and GMP – Records in Nutraceutical Manufacturing are designed to meet critical training needs in the multi-billion dollar nutraceutical sector, which includes products such as dietary supplements and functional foods.In the United States, the same strict GMP regulations that govern pharmaceutical manufacturers also apply to all companies that manufacture, package, label, or hold nutraceuticals or dietary supplements.  A key requirement of these regulations (specified in 21 CFR Part 111) is  for  all personnel to be trained in the proper use of SOPs (Standard Operating Procedures) and completion of records.Both e-Lessons are based on these regulations and are suitable for both ‘on-boarding’ of new hires and as refresher training material for existing employees.Accessed via the Internet or your company’s intranet/LMS, each e-Lesson is a rich multimedia learning experience that combines text, audio, graphics and animations to transfer critical knowledge in an engaging and interactive way.

 
 

nutraceuticals

January 15th, 2013: Nutraceuticals ManufacturingNGI Suite
Skillpad is currently working on a new suite of modules to meet the training needs of the multi-billion dollar nutraceuticals sector.A nutraceutical is a product isolated or purified from foods that provides health benefits that go beyond basic dietary needs i.e. it provides physiological benefits or protection against chronic disease. Examples of nutraceuticals include dietary supplements and functional foods.In the United States, the same strict GMP regulations that govern pharmaceutical manufacturers (specified in 21 CFR 210 and 211) also apply to all companies that manufacture, package, label, or hold nutraceuticals or dietary supplements.Skillpad’s Nutraceutical Essentials suite is specially designed to meet the training needs of personnel involved in the manufacture of nutraceutical products. The curriculum includes an overview of nutraceutical products, the applicable regulatory framework, GMP requirements and critical manufacturing issues such as dress codes and contamination prevention.

Curriculum Overview

1. Overview of Nutraceuticals and their Manufacture
This module introduces the nutraceuticals sector and describes the types of products that are manufactured. It provides an overview of what nutraceuticals are used for as well as the general organizational issues involved in their manufacture, storage and distribution.

2. Regulatory Framework for Nutraceuticals
This module explores the regulatory environment that governs the manufacture and marketing of nutraceuticals. It describes the mechanisms used by different regulatory agencies to ensure the safety and quality of nutraceutical products.

3. GMP for Nutraceuticals
What is GMP and why does it matter to the manufacture of nutraceuticals? This module discusses the fundamental principles of GMP and explains how they safeguard the user, minimize costs for manufacturers and improve manufacturing efficiency.

4. Dress Codes for Nutraceuticals Manufacture
This module explains dress codes typically used in nutraceutical manufacturing facilities and why they must be followed . Various examples of the protective clothing worn during different stages of manufacture are provided.

5. Contamination Prevention in Nutraceuticals Manufacture
This module explains the possible ways nutraceutical products can become contaminated during manufacture and how these risks can be minimized through the use of PPE and good sanitation habits.

 
To find out more about this exciting new product offering from Skillpad, contact us today!
 
December 6th, 2012: We have just released the first module of a brand new suite of drug development and clinical trials modules. Designed specifically for personnel working in pharmaceutical development, this suite of modules will cover all major aspects of new drug development and clinical trials processes. It will provide critical knowledge in key areas such as Good Clinical Practice, regulatory requirements, structure and format of clinical trials, roles and responsibilities, safety and documentation requirements. 
New Drug Development and Clinical Trials – CTM-800-01
This module describes the most important characteristics of drug products and explains why the development and testing of new drug products must be regulated. It provides an overview of the drug development process and the various phases of clinical trials and also introduces the concept of Good Clinical Practice (GCP).
 
November 6th, 2012: Skillpad is excited to announce its brand new suite of biopharma modules. Specifically designed for personnel working in biopharmaceutical  manufacturing, the module suite covers all major aspects of biopharmaceutical manufacturing and processing and  provides critical knowledge in key areas such as recombinant DNA technologies, upstream and downstream processing, and formulation and packaging. 

 

Biopharmaceuticals – An Overview – BPU-800-04
Introduction to biotechnology and biopharmaceuticals. The role of DNA and proteins in the body is explained along with the key techniques of Recombinant DNA Technology and Monoclonal Antibody Technology. The advantages and characteristics of biopharmaceutical products are explored and the main types of products described. Key differences between biopharmaceuticals and ‘traditional’ pharmaceuticals are also highlighted.

 


Clean In Place – BPU-801-01
Explains key concepts of Clean In Place (CIP) technology commonly used in the biotechnology and pharmaceutical industries. It describes CIP processes and procedures and provides examples of best practices that help ensure optimum performance.

 


Downstream Processing: Ultrafiltration and Diafiltration – BPU-802-01
Describes the  downstream manufacturing processes of ultrafiltration and diafiltration with an emphasis on post-harvest  volume reduction and concentration for therapeutic protein products. The components of an UF/DF skid and control of the UF/DF process are also described.

 


Downstream Processing: Centrifugation – BPU-803-01
Describes how centrifugation can be used in the downstream processing stage of biopharmaceutical manufacturing. The equipment and processes involved for both primary separation and more advanced separation tasks are described.


Bioreactors In Bioprocessing – BPU-804-01
Covers  the function, set-up and control of bioreactors in the biopharmaceutical industry. It also explores the design of bioreactors and their different modes of operation.

 


Overview of Biopharmaceutical Manufacturing – BPU-805-01
Explains the principles of biopharmaceutical manufacturing by focusing on the processes typically involved in producing therapeutic proteins. It will allow you to become familiar with critical concepts such as GMP and regulation, upstream and downstream processing, and formulation/fill finish.


Fermentation in Biopharmaceutical Manufacturing – BPU-806-01
Describes how microorganisms are used in fermentation processes as part of biopharmaceutical manufacturing. Areas covered include growth characteristics and conditions, cell banks, media, bioreactors and modes of operation, and the importance of sterility.


Cell Culture in Biopharmaceutical Manufacturing – BPU-807-01
Describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.

 


Cell Biology and Recombinant DNA Technology – BPU-808-01

Describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.
Provides an overview of the functioning of mammalian cells, the roles DNA and RNA play in the cell in producing proteins, and how these can be manipulated to produce therapeutic proteins and other useful biologics.

 


Formulation & Packaging in the Biopharmaceutical Industry – BPU-809-01
Provides an overview of the principles and practices of formulation and packaging in a modern biopharmaceutical manufacturing facility.

 

March 27, 2012: Skillpad is pleased to announce new lessons on GMP.

 


GMP: SOPs for Finished Dose ManufacturingPGI-800
This module defines Standard Operating Procedures (SOPs), why they are necessary, where they are used, the type of information they typically contain, and how they are controlled.

 


Personnel and TrainingPGI-810
This module defines GMP rules and regulations for organization, training, trainers and training records in a pharmaceutical manufacturing facility. It details the responsibilities of personnel regarding clothing, hygiene and health.

 

January 4, 2012: Skillpad is pleased to announce the launch of two new lessons on High-Performance Liquid Chromatography.

Introduction to HPLCPPL-830-01
Describes the basic theory and practice of HPLC. Particular focus is given to reverse phase HPLC. The components of a HPLC are described in detail and significant consideration is given to the explanation of results and peak shape. Analytical considerations of special relevance to HPLC are also presented. 
HPLC Troubleshooting – PPL-831-01
Describes the troubleshooting of common HPLC equipment problems. 

icon_articles

For more information about our full range of lessons, click here to download our catalog.

contact us

For more information on these lessons or to arrange an online demonstration, contact us today.