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FDA Regulation of Dietary Supplements

Dietary Supplement Health and Education Act

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health read more

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  • 1 hour · Self-paced
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FDA's New Import Program for 2020

Harmonized Tariff Schedule (HTS)

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. read more

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  • 1 hour · Self-paced
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FDA Compliance for Mobile Applications

Mobile Applications

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

Attend this webinar to understand the FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special attention read more

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  • 1 hour · Self-paced
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Project Management for FDA-Regulated Companies

Project Management

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

...documented rationale. Three of the most common tools will be discussed. Why you should Attend: The FDA expects companies to manage projects formally to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD read more

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  • 1 hour · Self-paced
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FDA's New Import Program for 2020 and Impact of the COVID-19

Harmonized Tariff Schedule (HTS)

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS). The FDA and U.S. Customs and Border Protection are using new read more

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  • 1 hour · Self-paced
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FDA Regulation of Artificial Intelligence/ Machine Learning

Machine Learning

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance's for years, however, AI/ML programs fall outside the scope of these regulations read more

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  • 1 hour · Self-paced
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  • Online
  • 1 hour · Self-paced
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This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just read more

  • Online
  • 2 hours · Self-paced
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Computer System Validation (CSV) for FDA-Regulated Computers

Computer System Validation

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system read more

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  • 2 hours · Self-paced
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Good Documentation Practices to Support FDA Computer System Validation

Computer System Validation

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
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As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's read more

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  • 2 hours · Self-paced
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FDA's Cloud Compliance & Regulations

Strategic Management

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

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  • 1 hour · Self-paced
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Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

How people interact with medical devices.

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

...the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document. Why you should Attend: The FDA will only approve devices which read more

  • Online
  • 3 hours · Self-paced
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3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

Social Media Promotion

NetZealous LLC
£242
  • Online
  • 3 hours · Self-paced
  • Tutor support

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational read more

  • Online
  • 2 hours · Self-paced
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Technical Documentation Files - The US FDA and EU MDR Requirements

European Union Regulatory Requirements

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

..."Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring changes and/or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed. Why read more

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  • 1 hour · Self-paced
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Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

How to Conduct a Human Factors

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative read more

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  • 1 hour · Self-paced
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The 6 Most Common Problems in FDA Software Validation and Verification

Webinar on FDA Software Validation and Verification

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

...equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and "wheel spinning." Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. Why you should Attend: Avoid the 6 read more

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  • 2 hours · Self-paced
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The 6 Most Common Problems in FDA Software Validation and Verification

Webinar on FDA Software Validation and Verification

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

...equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and "wheel spinning." Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. Why you should Attend: Avoid the 6 read more

  • Online
  • 3 hours · Self-paced
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3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look

When Conducting cGMP Regulatory Inspections

NetZealous LLC
£242
  • Online
  • 3 hours · Self-paced
  • Tutor support

It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation read more

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  • 1 hour · Self-paced
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21 CFR Part 11 - Compliance for Electronic Records and Signatures

Compliance for Electronic Records and Signatures

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
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This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA read more

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  • 2 hours · Self-paced
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Verification vs Validation-Product, Process or Equipment and QMS Software

This webinar will address the use of the FDA, GAMP, 21 CFR Part 11

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other read more

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  • 2 hours · Self-paced
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Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Knowledge of regulatory requirements

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
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Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory read more

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  • 1 hour · Self-paced
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Responsibility for Off-label Claims in Social Media

Webinar on Responsibility for Off-label Claims in Social Media

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
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FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform. If the information can reach a consumer, FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers read more

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  • 1 hour · Self-paced
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Medical Device Risk Management following ISO 14971:2019

Medical Device Risk Management

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
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The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a read more

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  • 2 hours · Self-paced
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Handling OOS Test Results and Completing Robust Investigations

Handling OOS Test Results

NetZealous LLC
£170
  • Online
  • 2 hours · Self-paced
  • Tutor support

...investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are not followed. This webinar will guide attendees through the entire process from detection an out-of-specification result read more

  • Online
  • 2 hours · Self-paced
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  • Online
  • 2 hours · Self-paced
  • Tutor support

...climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. The conversion read more

  • Online
  • 1 hour · Self-paced
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How to Conduct a Human Factors/ Usability Validation

How to Conduct a Human Factors

NetZealous LLC
£140
  • Online
  • 1 hour · Self-paced
  • Tutor support

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantatative read more

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reed.co.uk offers a large variety of FdA courses which you can choose from based on your learning needs and goals. The FdA courses on offer vary in time duration and study method, with many offering tutor support. Depending on your learning outcomes, reed.co.uk also has FdA courses which offer CPD points/hours or qualifications.

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