Online Training
COVERING IMPORTANT REGULATIONS
ONLINONLONINE
Learn about the laws and regulations that govern the life science industry.
Benefits of web based training include:
- Optimize productivity and training time
- Flexible mobile learning using a desktop, laptop, tablet or mobile device
- Fulfill new hire and annual FDA training requirements
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ADDITIONAL ONLINE COURSES:
FDA 21 CFR Part 820 for MEDICAL DEVICES
FDA 21 CFR Part 820 details the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with regards to their quality system.
These courses detail important aspects of 21 CFR 820:
Quality System Regulation (QSR) for Medical Device
Learn why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers, with focus on FDA 21 CFR Part 820 Quality System Regulation, and a comparison to the ISO standard 13485.
LEARN MORECombination Products
Learn Current Good Manufacturing Practice (cGMP) regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries.
Good Documentation Practices
This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.
Introduction to Design Control
Understand why the Design Control is important, how it supports your overall business, and identify the elements, phases, and process for design control, as laid out by FDA 21 CFR 820.30.
Introduction to Investigations and CAPA
This one hour web based training course provides an overview of the Investigations and CAPA system and process. It highlights the key compliance drivers and regulatory requirements from CFR 820.100. Understand correction, corrective action, and prevention.
FDA 21 CFR Part 210, 211
FDA 21 CFR Part 210 is a part of cGMP’s for the processing, packing, or holding of Drugs. 21 CFR Part 211 covers finished pharmaceuticals. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMP’s help ensure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
These courses detail important aspects of 21 CFR 210-211:
Current Good Manufacturing Principles (cGMP)
This course provides a breakdown of the current Good Manufacturing practice requirements and includes subpart detail, and covers 21 CFR Part 210 & 211 in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceutical.
LEARN MORECombination Products
Learn Current Good Manufacturing Practice (cGMP) regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries.
Good Documentation Practices
This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.
FDA 21 CFR Part 600, 601, 610
FDA 21 CFR part 600 covers the Current Good Manufacturing Practices (cGMP) requirements for the manufacturer of Biological Products. 21 CFR part 601 covers licensing of biological products, and 21 CFR 610 is for release of Biological products.
These courses detail important aspects of 21 CFR 600, 601, and 610:
Biologics
Gain a high-level understanding of the regulations for the Biologics industry, with a breakdown of the FDA requirements in 21 CFR parts 600, 601, and 610. Understand general requirements, licensing, and biologics standards.
LEARN MORECombination Products
Learn Current Good Manufacturing Practice (cGMP) regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries.
Electronic Records and Signatures
Review the requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems and electronic signatures. Know the importance in using good documentation practices as we transition to a more paperless society.
LEARN MOREQuality System Regulation (QSR) for Medical Device
Learn why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers, with focus on FDA 21 CFR Part 820 Quality System Regulation, and a comparison to the ISO standard 13485.
LEARN MOREICH E6 (R1, R2)
The International Council for Harmonisation ICH is an international body that sets the standards for regulations of clinical trials involving human subjects. E6(R1) is the standard used for clinical trials. R2 is an addendum to E6(R1) that provides Good Clinical Practice (GCP) guidance and a unified standard for the European Union, Japan, and the United States.
These courses detail important aspects of these regulations:
Good Clinical Practices (GCP)
Understand the international standard for organizations involved in clinical trials or studies. Understand GCP, including the recent updates to the regulations in E6(R2), ICH E6(R1), how the regulation came to be, and why they are essential for your organization.
LEARN MOREGood Documentation Practices
This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.
Electronic Records and Signatures
Review the requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems and electronic signatures. Know the importance in using good documentation practices as we transition to a more paperless society.
LEARN MOREFDA 21 CFR Part 3, 4, 21st Century Cures Act
FDA 21 CFR part 3 covers the jurisdiction of the product, based on its product classification. 21 CFR part 4 is for the regulation of Combination Products.
The 21st Century Cures Act prevents blocking of patient data between systems and devices.
These courses listed below detail important aspects of 21 CFR Part 3 & 4, as well as the 21st Century Cures Act for :
Combination Products
Learn Current Good Manufacturing Practice (cGMP) regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries.
Quality System Regulation (QSR) for Medical Device
Learn why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers, with focus on FDA 21 CFR Part 820 Quality System Regulation, and a comparison to the ISO standard 13485.
LEARN MORECurrent Good Manufacturing Principles (cGMP)
This course provides a breakdown of the current Good Manufacturing practice requirements and includes subpart detail, and covers 21 CFR Part 210 & 211 in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceutical.
LEARN MOREGood Documentation Practices
This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.
FDA 21 CFR Part 11, Public Docket 92S-0251
FDA 21 CFR part 11 is the guidance for those organizations who have chosen to maintain their records or submit designated information electronically, and use electronic records and/or signatures in their system.
Public Docket 92S-0252 provides a list of FDA units that are can receive electronic submissions, as well as the specific types of records and submissions that can be accepted in electronic format.
These courses listed below detail important aspects of these regulations:
Electronic Records and Signatures
Review the requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems and electronic signatures. Know the importance in using good documentation practices as we transition to a more paperless society.
LEARN MOREGood Clinical Practices (GCP)
Understand the international standard for organizations involved in clinical trials or studies. Understand GCP, including the recent updates to the regulations in E6(R2), ICH E6(R1), how the regulation came to be, and why they are essential for your organization.
LEARN MOREGood Documentation Practices
This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.
ISO 13485: 2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
These courses listed below detail important aspects of this regulation:
ISO 13485: 2016
The PathWise ISO 13485 training for medical device manufacturing online course covers outlines key areas, including the emphasis on risk management and risk-based decision making.
LEARN MOREQuality System Regulation (QSR) for Medical Device
Learn why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers, with focus on FDA 21 CFR Part 820 Quality System Regulation, and a comparison to the ISO standard 13485.
LEARN MOREGood Clinical Practices (GCP)
Understand the international standard for organizations involved in clinical trials or studies. Understand GCP, including the recent updates to the regulations in E6(R2), ICH E6(R1), how the regulation came to be, and why they are essential for your organization.
LEARN MOREEU MDR 2017/745
The EU MDR is the regulation for the European Union. If you are a manufacturer, authorized representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to understand how to comply with this regulation
These courses listed below detail important aspects of this regulation:
EU MDR 2017/745
Learn the changes with the EU MDD transitioning to the EU MDR. Understand the key updates and differences, and what you must do i your organization to remain compliant.
LEARN MORE
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