Risk Management
This international standard focuses specifically on risk management for medical devices and is referenced in ISO 14971
What is IEC 62366?
Under 21 CFR 211, this independent department must have the authority to approve or reject all components, drug products, and procedures.
What is the Quality Unit?
According to 21 CFR 820.30, this comprehensive document contains or references the records demonstrating compliance with design control requirements.
What is the Design History File (DHF)?
CMC stands for what.
This World War II aviation psychologist pioneered human factors work.
Who is Alphonse Chapanis?
This FDA-mandated program can include Elements to Assure Safe Use (ETASU) for high-risk medications.
What is REMS (Risk Evaluation and Mitigation Strategies)?
This document contains complete manufacturing formulas, processing instructions, and in-process control procedures for drug manufacturing.
What is a Master Production Record?
In the FDA design control model, this process confirms that the design outputs meet the design inputs.
What is design verification?
CMC information is found in Module 3 and what other module in a CTD-style submission?
What is Module 2?
IEC 62366-1 defines this systematic process for analyzing, specifying, developing, and evaluating usability of medical devices.
What is the usability engineering process?
This foundational pharmaceutical quality risk management guideline is structured around assessment, control, communication, and review of risks.
What is ICH Q9?
According to 21 CFR 211, this type of thorough investigation is required for any unexplained discrepancy or failure of a batch to meet specifications.
What is a product investigation?
21 CFR 820.30 requires these formal documented reviews of design results to be conducted at defined checkpoints during device development.
What are design reviews?
In regulatory submissions, this document defines the target attributes of a drug product and forms the basis for the development of the control strategy.
What is the Quality Target Product Profile (QTPP)?
This type of evaluation is performed after the design is complete and before market release, using representative users in appropriate numbers.
What is summative evaluation?
In ISO 14971, these three activities—risk analysis, risk evaluation, and risk control—collectively make up this broader process.
What is risk management?
These samples must be retained for at least one year past the expiration date and in quantities at least twice what's needed for all tests required.
What are reserve samples?
Under 21 CFR 820, this process confirms that device specifications conform to user needs and intended uses.
What is design validation?
These quality attributes constitute approximately one-third of review issues in drug applications.
What are CMC issues?
The medical device usability slides identified these scenarios as requiring documentation according to IEC 62366, where use errors could lead to harm.
What are hazard-related use scenarios?
Under ICH Q9, this mathematical ratio used to evaluate pharmaceutical quality risk is calculated by dividing a process parameter's natural variation by its specification limits.
What is process capability (Cp/Cpk)?
In pharmaceutical manufacturing, this documented evidence demonstrates that a process consistently produces product meeting predetermined specifications and quality attributes.
What is process validation?
According to 21 CFR 820, this required document contains the procedures and specifications for a finished device, including manufacturing methods and quality assurance specifications.
What is the Device Master Record (DMR)?
This timing recommendation for CMC planning should begin 18-24 months before submission.
What is the critical timeline for CMC submission preparation?
The iterative design phase related to human factors engineering involves this kind of testing.
What is formative testing?