Simplifying Global Compliance
Medical Device Quality & Compliance Institute 2012 Quality Systems and Design Control Training
| Quantity Discounts | 1 - 9999 $3,000.00 | 1 - 9999 $1,495.00 | 1 - 9999 $1,995.00 |
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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 2012: Quality Systems and Design Control Training — two courses presented by EduQuest in cooperation with FDAnews that are offered separately or as an integrated three-and-a-half-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 three-and-a-half 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).
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.
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.
Save $490 Now:
Former FDA Investigators Ready to Give You "Insider Advice"
When You Choose the Three-and-a-Half-Day Training Package
Choose one course or both courses (see the schedule below) 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 (12 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 day-and-a-half 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.
You'll learn:
- 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.
You'll learn:
- 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
Deploy an arsenal of compliance knowledge
and rank at the top at your next FDA visit.
Register now for Medical Device Quality & Compliance Institute 2012.
Get three-and-a-half days of hands-on, interactive training!
Course instructors have trained the FDA's own investigators
— and some are former FDA investigators themselves.
Denise Dion, the course leader, is the Vice President of Regulatory and Quality Services for EduQuest, a global team of FDA compliance experts headquartered near Washington, DC. Ms. Dion spent 18 years with the FDA, where she served as an Office of Regulatory Affairs headquarters' authority on agencywide inspections and investigations. She developed many of the FDA's inspection guidance and training materials, including serving as the primary editor of the well-known FDA Investigations Operations Manual (IOM). Ms. Dion was the primary contact for interpretation and request for changes and additions to the IOM. In addition, she was one of the authors and trainers of the Quality System Inspection Technique (QSIT). For her EduQuest clients, Ms. Dion provides regulatory guidance with particular emphasis on cGMPs, GCPs, quality systems, CAPA systems, risk management, bioresearch monitoring, and FDA inspections and enforcement. She regularly performs audits to assess regulatory compliance with drug, medical device and biologics regulations.
Gordon B. Richman is the Vice President of Strategic Compliance Consulting for EduQuest. He brings over 25 years of regulatory, legal and corporate management experience to these training courses. In industry, he held increasingly responsible senior management positions with leading pharmaceutical and medical device companies, first as Director of Worldwide Quality Strategy in GlaxoSmithKline's Global Manufacturing and Supply operations, then as Vice President of Regulatory Compliance at Fisher & Paykel Healthcare and Vice President of Regulatory Affairs at Masimo Corporation. Previously, he spent several years in FDA regulatory practice with major law firms in Washington, DC, where he advised and defended pharmaceutical and medical device companies on a broad range of FDA regulatory issues.
Save When You Register for Both Courses
Register now for both Medical Device Quality & Compliance Institute's training courses and save. See the schedule below.
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Send Your Compliance Team for Minimal Cost and Maximum Benefit!
Get your compliance team up to speed in just one week and save! Significant Tuition Discounts — Register 4 members for the same course and send the 5th member for FREE. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 or toll free (888) 838-5578 to make your team reservation. |
- Device industry managers
- Quality assurance and quality control specialists
- Regulatory affairs professionals
- Medical professionals
- IT engineers
- Manufacturing engineers
Medical Device Quality & Compliance Institute is offered at the following location:
April 17-20, 2012
Hampton Inn and Suites Frederick-Fort Detrick
1565 Opossumtown Pike
Frederick, MD 21702
www.frederickfortdetricksuites.hamptoninn.com
Reservations: 301-696-1565
Room rate: $119 per night, plus tax (Please mention discount code: EDQ)
Reservation cut-off date: April 6, 2012
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Course #1: QSR Compliance Basics: Complying with the FDA's Medical Device 21 CFR 820 Quality System Regulation
(12 Course Hours) |
Course #2: Design Control & Transfer for Medical Devices: Meeting the FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing
(16 Course Hours) |
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| Fee |
$1,495
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$1,995
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| Dates and Times |
Tuesday 8:30 a.m. – 5:30 p.m.
Wednesday 8:30 a.m. – 12:30 p.m. |
Wednesday 1:30 p.m. – 5:30 p.m.
Thursday 8:30 a.m. – 5:30 p.m. Friday 8:30 a.m. – 12:30 p.m. |
Register NOW for Both Courses and pay only $3,000 —
A Savings of $490
Space is limited — Register today!
Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
Cancellations and Substitutions
Cancellations received before the beginning of a course will be subject to a refund according to the following schedule and rates: A 95% refund will be provided for cancellations received up to 6:00 PM EST, 10 business days in advance of the course start date. If less than 10 business days’ advance notice is provided, the refund amount will be reduced to 50%. Substitutions are permitted with prior notification to FDAnews. Individuals requesting to change course location less than 10 business days in advance of the course will be charged a $500 administrative fee. No-shows will be charged the full amount. FDAnews reserves the right to cancel the courses and is not responsible for any airfare, hotel, or other costs incurred by registrants.
We look forward to having you join us.
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