The experts who offer the FDA Compliance Boot Camp are now adding two intensive medical device training courses.
FDA says approximately 44% of device recalls are due to faulty design.
Recalls are expensive, embarrassing, and often lead to more serious financial consequences — not only from the FDA but also from courts and unhappy shareholders.
Stop spinning your wheels with nonessential activities that waste time and money. To survive in today's tough economy and ultra-competitive medical device market, you need a quality system that works from the get-go — from the start of product design continuing through component selection, manufacturing, use and disposal.
Register now for Medical Device Quality & Compliance Institute 2016: Quality Systems and Design Control Training — two courses presented by EduQuest in cooperation with FDAnews that are offered separately or as an integrated four-day learning package — and learn how to develop a by-the-book quality management program. Leave the guessing to your competitors.
Discover how to overcome one of the biggest obstacles device manufacturers face — how the FDA expects you to develop and implement design controls, then transfer product design to manufacturing operations.
With four days of intensive training you'll walk away with the compliance guidance and insight you need to meet FDA standards with confidence.
Learn straight from the source — former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Your instructors include one of the co-authors and trainers of the FDA's Quality System Inspection Technique (QSIT) and the founding editor and co-author of the FDA's "bible" for inspectors, the Investigations Operations Manual (IOM). Your instructor also served on FDA’s Design Control Inspection Strategy team, giving you even more insights into the Agency’s approach to evaluating your Design History Files, Design Master Records, and more.
Through plain-English instruction, detailed course materials, and interactive exercises that reinforce the lessons (not to mention making the classroom more fun and interesting), you'll learn to cost-effectively comply with the FDA's QSR rules and related international standards.
Register today to reserve your free copy of EduQuest’s
Quality Systems/Design Control Resource CD
Receive EduQuest’s Quality System Regulation (QSR) and Design Control Resource CD – an electronic reference library of quality system and FDA compliance resources – free with your class attendance at either QSR Compliance Basics or the Design Control course.
A $195 value, the Resource CD gives you access to a treasure-trove of FDA laws, regulations and guidance, inspection protocols, warning letters, international guidelines, and EduQuest compliance advisories.
The CD is designed by the class instructors specifically for those who develop, manage and implement quality systems and those who design and engineer medical device and diagnostic products.
Quality Systems and Design Control Resource CD Table of Contents:
- Unabridged text of laws enforced by FDA
- Unabridged text of key regulations enforced by FDA – Title 21 CFR
- Library of FDA Guidance Documents related to quality systems, inspection preparedness, audits, and supplier management
- Relevant FDA warning letters, court decisions, and consent decrees
- International guidance documents and guidelines (including PIC/S, GHTF, ICH, and EudraLex)
- Latest version of FDA’s Investigations Operations Manual (IOM)
- CAPA decision flow chart
- Points to consider when preparing for an FDA inspection under the QSIT CAPA subsystem
- Links to FDA Dashboard for inspection, compliance and recall data
- EduQuest Compliance Advisories: FAQs, white papers, reports and expert tips for compliance and best practices
- Archive of previous editions of EduQuest-ions & Answers compliance advice
Specifically targeted to device manufacturers and suppliers, now you can gain a thorough understanding of the massive 21 CFR 820 Quality Systems Regulation requirements. Know what it takes to stay in compliance and avoid the risk of your product not getting to market or being removed from the market once it's there.
Choose one course or both courses (see the schedule) to suit your needs and fit your schedule. Following is a list of the courses and learning objectives of each.
Course #1 — QSR Compliance Basics: Complying with the FDA's Medical Device 21 CFR 820 Quality Systems Regulation (16 Course Hours)
Compliance with the FDA's Quality Systems approach is recognized globally as a prerequisite not only for getting your product on the market but — just as importantly — keeping it there.
The two-day QSR Fundamentals course walks you through the requirements of 21 CFR 820, discusses how the FDA's rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.
The FDA's Evolving Approach to Quality Systems
- Scientific foundations of quality systems
- Key quality system elements according to ISO and the FDA
- Speaking the lingo: important cGMP terms and definitions
An Introduction to the FDA's Quality Rules for Medical Devices
- Core principles
- Quality and compliance: two sides of the same coin
- Seven FDA-recognized subsystems of your quality system
ISO/ICH Approaches to Quality Systems
- Comparison of international standards to FDA expectations
- ISO 9001:2008 quality system requirements
- Relationship to ISO 13485: 2003
QSR Management Review and Control (Subpart B)
- Management and executive responsibilities
- Developing a quality policy
- Allocating adequate resources
QSR Design Controls and System Development (Subpart C)
- Tools for design control
- Research vs. design
- Design verification and validation
QSR Production and Process Controls (Subparts G, O)
- Tools for controlling and monitoring processes
- Process validation
- Computerized system validation, including validating off-the-shelf software
QSR Corrective and Preventive Actions - CAPA (Subparts J, I, N)
- Difference between correction and corrective action
- Examples of preventive action
- Evaluating CAPA sources
The Yin and Yang of Design/CAPA
- The FDA's trending requirement
- ISO 9001:2008 trending requirement
Laboratory Controls for Combination Products (21 CFR Part 211 Subpart I)
- Process tasks for laboratory controls
- Documenting laboratory operations
- Validating laboratory test methods
Conducting Failure Investigations
- Importance of identifying root cause
- Seven basic investigation tools you should know
- Best practices for reducing failures
QSR Documents, Records and Change Control (Subparts D,M)
- Assuring changes are reviewed and approved
- Tools for change control
QSR Facility and Equipment Controls (Portions of Subpart G)
- Minimizing adverse impacts of manufacturing environment
- Tools for facility and equipment control
- Key environmental controls
QSR Material Controls (Subparts E, F, H, K, L)
- Evaluating suppliers, contractors and consultants
- Tools for material controls
How to Prepare for an FDA QSR Inspection
- Understanding the FDA's Quality System Inspection Technique (QSIT)
- Quality system objective evidence the inspector will want to see
- Examples of systems-based questions to use to prepare
FDA Enforcement Priorities
- Understanding the FDA's mindset
- Inspection observations and reports
- Consequences of noncompliance
- Recent trends in FDA 483 observations
- Practical suggestions for surviving an inspection
Course #2 — Design Control for Medical Devices: Meeting the FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing (16 Course Hours)
Then take the next step with the two-day Design Control and Transfer course. Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there's relentless pressure from both the FDA and Congress to improve device design control and manufacturing.
By registering for the Design Control and Transfer course, you'll learn how the FDA expects you to develop, implement, and manage design control. You'll also focus on overcoming one of the biggest obstacles that regularly confounds device companies — accurate and consistent transfer of product design to actual manufacturing operations. Moreover, you'll learn how the FDA's design control rules relate to product quality standards established in ISO 9001:2008 and ISO 13485.
Why the FDA Requires Design Controls
- The FDA's major areas of concern
- CDRH's cradle-to-grave vision: The Total Product Life Cycle
- Design control as part of the Quality System Regulation (QSR)
- The FDA's definition of key design terminology
The FDA's Guidance for Design Controls
- Defining a "substantially equivalent" production unit
- Understanding difference between a deviation and nonconformance
- Understanding difference between project design and product design
- How international standards relate to the FDA's expectations
Design and Development Planning - 21 CFR 820.30 (b)
- Implementing top-level design control procedures
- Elements of the general development
- Best practices in design planning
Design Review - 21 CFR 820.30 (e)
- Types of review
- Proven design review methods
Design Input - 21 CFR 820.30 (c)
- Understanding inputs vs. outputs
- Typical input documents
- Using FDA-recognized standards and guidance
- Importance of human factor considerations
- Good and bad examples of requirements
Design Output - 21 CFR 820.30 (d)
- Process controls outputs
- Other final output documents
- Conducting design output review
Design Verification - 21 CFR 820.30 (f)
- Verification documents
- Understanding difference between verification and validation
- Elements of a test protocol
- What the FDA looks for in test reports
- What if the design fails verification and validation?
Design Validation - 21 CFR 820.30 (g)
- How the FDA defines validation
- Key validation documents and methods
- Conducting design validation review
Design Change - 21 CFR 820.30 (i)
- Developing a change control policy
- Role of planned, temporary changes
- Identifying all areas impacted by change
- Conducting reverification and revalidation
Design Transfer to Manufacturing - 21 CFR 820.30 (h)
- Integrating manufacturing considerations into design
- Key design transfer documents
- Developing a manufacturing and transfer plan
- Proven design transfer methods
Lessons Learned in Design Transfer
- Documentation reminders
- Impacts on tooling and components
- Conducting design transfer review
- Importance of process control review
Design History File (DHF) - 21 CFR 820.30 (j)
- FDA requirements for design history
- Responsibilities of team leaders
- Relationship between the DHF and the Device Master Record
- Creating a traceable DHF index
- Practical suggestions maintaining compliance
Register now for Medical Device Quality & Compliance Institute 2016.