Pack of FIVE : Best FDA Courses

Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment using real-world data to improve performance. Thus the field version of the software is no longer the validated approved version.

This training will address the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Development personnel should understand these concepts because, with some modifications, they will become regulations.

It is not clear how to get AI/ML programs approved. Following a discussion of possible future regulations, we will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now.

Necessary submission documentation will be explained.

This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML. Attendees will receive a multipage outline and checklist.

Why should you Attend:
It is not clear how to get AI/ML programs approved. The current regulatory requirements don’t control AI/ML adequately.

We will discuss the approaches FDA is considering for regulation in the near future and how to get your AI/ML program approved by FDA now. Necessary submission documentation will be explained.

Attendees will receive a multipage outline and checklist.

Areas Covered in the Session:

• Total product life cycle approach to AI/ ML design
• Application of FDA software Pre Cert program to AI/ ML
• FDA discussion paper on AI/ML
• Database management
• QC of datasets
• Algorithm updating
• Reference standard development
• Standalone performance testing
• Clinical performance testing
• Data enrichment
• Emphasis on "explainability"
• Additional labeling requirements
• Cybersecurity

Who Will Benefit:

• Software Engineers
• Engineers
• Regulatory personnel
• Quality Assurance personnel
• Marketing
• Management

Overview: This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation and how to use ISO62304 to establish risk level. How software requirements are used in validation will be described. We will discuss risk based testing and the amount of documentation, based on risk, to be submitted to the FDA, following the 2023 Guidance.

Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the risk based testing that is required to produce a validated software product and the documentation to be submitted to the FDA.

Handouts are software traceability matrix form, validation plan template, and validation report form


Areas Covered in the Session:

• Software validation is more than testing
• Requirements traceability
• Risk analysis
• Unit, integration and system testing
• Algorithm validation
• Challenges to the software
• Configuration management

Who Will Benefit:

• Engineering Personnel
• Software Developers
• QA Management

Overview: 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 Guidance will be explained.

FDA-regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.

FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed, and hybrid (paper and electronic) systems will be explained.

Why should you Attend:
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation.

This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts.

Areas Covered in the Session:

• Origin of the Regulation and Changes in Interpretation
• Electronic Records
• Electronic Signatures
• Data Security
• Open, closed and hybrid Systems
• Validation Methods
• Risk Analysis

Who Will Benefit:

• Engineering Personnel
• QA
• IT
• Management

Overview: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as understand exactly where the instruction's weaknesses are so that procedures can be human-engineered, improved, and fixed.

Why you should Attend:
Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. Procedures are essential for both execution and audits.

These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. We will discuss content development to formats designed for human error reduction due to procedures.

Areas Covered in the Session:

• SOP writing outline
• Content development
• The rationale for procedure use
• Regulatory compliance background
• Universal purpose of procedures
• The Human Perspective
• Human Error as a root cause
• The thinking and reading process
• Common mistakes and causes
• How to create and maintain a procedure
• Goals of a procedure
• Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of "Precautions", "Warnings" and "Cautions"
• Procedure styles
• Use of electronic information networks for procedure access
• Use of AI to write procedures

Who Will Benefit:

• QA/QC Directors and Managers
• Process Improvement/Excellence Professionals
• Training Leaders and Managers
• Plant Engineering
• Compliance Officers
• Regulatory Professionals
• Executive Management
• Manufacturing Operations Directors
• Human Factors Professionals

Overview: Verification and validation of design inputs is a critical step in the development of medical devices. It is the objective evidence that the developer developed what they set out to develop and the final product meets its design goals and needs of the end user. Without proper verification/validation of inputs, it is not possible to prove to regulatory agencies that you have a product which is safe and effective and that it meets its design requirements.

Why should you Attend:
In the development of medical device, uncomplete understanding and implementation of design controls will lead to rejection of an application for approval by the FDA or rejection of a CE mark application. Incomplete, improper or missing verification and validation is a cause of many products not being approved for market. This seminar will give the participants the basics to be able to work through the concepts of design verification/validation and implement these concepts in their respective areas.

Areas Covered in the Session:

• Overview of where inputs (requirements) and V&V fit into the general flow of design control
• Regulatory Requirements
• A look at Design Inputs
• Where do they come from
• Flow
• Traceability
• Verification of Product Requirements
• Validation of User Needs
• Trace matrix and summary reports
• Conclusions

Who Will Benefit:

• This Webinar is appropriate to Anyone Working in Design, Development, Marketing or Support of Regulated Medical Devices
• People working in R&D, Quality Assurance, Validation, Regulatory Affairs, Marketing, Production and Product Support will Benefit from this Information