Validation – Regulation – Classification – Quality Systems.
Information and training presentation.
- Validation, explained in an easy to understand, logical format.
- Validation requirements from product design, through manufacturing and end use.
- Use to develop your personal understanding.
- View, when and where suits, from the convenience of your desktop, laptop, tablet, mobile.
- Use in the training of your work peers.
- 780 pages of information.
- Price $19.
Introduction to Regulatory Requirements and International Standards related to Medical Device Validation.
The key US and European regulations related to Medical Devices. Expectations for requirements such as the FDA’s 21 CFR Part 820. Basic Principles, Concepts, Terms & Definitions related to Validation.
How to implement Medical Device Process Validation.
Implementation of Production & Process Controls. When do you need to Validate a process (versus Verification). Examples of processes that should be Validated. Examples of processes that may be Verified. How do I know if a process cannot be fully Verified?
US FDA approach to Medical Device Regulation
Establishment registration, 510(k), PMA, Labels, …..
US FDA Medical Device Classification.
FDA classification structure, approval requirements, ….
Medical Device Regulation in Europe.
The key Medical Directives. Roles and responsibilities of the Notified Bodies, Competent Authorities, Authorized Representatives. The 10 stages to medical device product approval and “CE” certification.
ISO13485: 2016 revision changes – Medical Devices – Quality Management Systems.
Review of requirements. This standard was published (officially updated) on 1st March 2016. Information on the changed areas of focus inherent in the new revision.
Medical Device Validation of product and process Software.
Guidance for Software Validations. Categories of Software. The Software Life Cycle. User Requirements Specification. Software Design Specifications. Integration and Acceptance Test Specifications. Verifying Test Steps. Expected Outputs and Evaluation Criteria. Extent of software validation to be performed.
Medical Device Validation in the Design and Development process.
Quality System Requirements for Design Controls. Design Input & Output, Expectations, Regulations & Examples. Rationale for Design Control Requirements. The Process of Design Control. Design and Development Planning. Design Input types, sources, considerations, etc.. Design Output expectations. Performing Design Reviews. Creating and maintaining the Design History File.
The Life Cycle Approach to Medical Device Validation.
Implementing a Life Cycle Approach. Installation Qualification (I.Q.). Operation Qualification (O.Q.). Pre-Validation Study (PVS). Performance Qualification (P.Q.).
Implementing an on-going re-Validation process.
Re-validation and Change Control. Review and evaluation of re-validation. Significance of “where appropriate” in revalidation.
Creating a comprehensive Validation Master Plan (VMP).
The Validation Master Plan (VMP) development process. Why is a VMP necessary? Who prepares and approves the plan? How do you prepare & assemble a plan? Elements of a Validation Master Plan. Implementation of the VMP.
How to perform a Validation Gap Analysis.
The role of gap analysis. How to plan and develop a gap analysis to assess compliance. Typical assessment Tools and Techniques. Determining the methodology to use. Preparing for issues that may be found. Applying risk-based re-mediation.
Current Good Manufacturing Practices (cGMP’s).
Principles of current Good Manufacturing Practice (cGMP). The concept of a device being “fit for intended purpose”. The FDA Quality System Regulations (QSR’s) explained.
The key validation related components of an effective Quality Management System.
… Documentation. Determining the necessity for documentation. Review of the various types of documentation. Implementing and maintaining compliant Standard Operating Procedures. Understanding the fundamental documentation rules. Maintaining a controlled documentation process.
How to identify the need for Validation based on identifying and quantifying Risk.
Why use a risk based approach? Considerations of the ISO standard to Risk Management, i.e. EN ISO 14971. What are the various Risk Assessment Tools and Techniques. The suitability of the various techniques to assessing risk.
Packaging in the Medical Device industry.
Characteristics of healthcare products that influence their packaging requirements. U.S. and European regulations related to device packaging. Most widely utilized device package types. Key symbols to be applied to medical device packaging.
Planning, documentation and reporting Validation Protocols.
Qualification Report content. Protocol Report summary. Data Analysis summary. Exception statements.