Monday & Tuesday, September 18-19, 2017
Near Baltimore and Washington, DC
Fully understand your company’s obligations to develop and maintain an effective Quality System under the 21 CFR 820 regulations
Learn straight from the source -- former FDA investigator Denise Dion, co-architect of FDA's QSIT -- the Agency's medical device inspection protocol
Get interactive, real-world classroom training on the essential FDA Quality System rules you must know to prepare for your next inspection or 3rd-party audit
The scope of FDA’s Quality System Regulation (QSR) is huge – more than 500 pages of rules and guidance – and non-compliance is not an option. Just within the past 18 months, more than two dozen medical device companies have received Warning Letters for deficient quality management programs, and several were threatened with removal of their products from the market.
Compliance with FDA’s Quality System approach is recognized globally as a pre-requisite not only for getting your product on the market but – just as importantly – keeping it there. This two-day QSR Basics course walks you through the requirements of 21 CFR 820, discusses how FDA’s rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.
Learn straight from the source – former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Instructors include one of the co-authors and trainers of FDA’s Quality System Inspection Technique (QSIT) and the founding editor and co-author of FDA’s “bible” for inspectors, the Investigations Operations Manual (IOM).
Why you should attend:
Fully understand your company’s obligations under 21 CFR 820
Your instructors are former FDA medical device investigators, including the founding editor and co-author of the FDA’s “bible” for inspectors, the Investigations Operation Manual (IOM), as well as experts from the regulated community
Hear “lessons learned” by other device companies who have been cited by FDA for deficient quality management
See how FDA rules relate to ISO and ICH standards – and save time and money with an integrated compliance blueprint
Learn to quickly capture feedback – both internal and external – to fine-tune your quality system and avoid product seizures and recalls
Compare notes with other device manufacturers who face challenges similar to yours
Receive a Certificate of Completion to document your training to senior management and FDA inspectors
QSR Compliance Basics:
Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation
Day 1: 8:30 a.m. – 5:00 p.m.; Day 2: 8:30 a.m. – 5:00 p.m. U.S. Eastern Time
FDA's Evolving Approach to Quality Systems
Scientific foundations of quality systems
Key quality system elements according to ISO and FDA
Speaking the lingo: important cGMP terms and definitions
Introduction to FDA's Quality Rules for Medical Devices
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 quality system requirements
Relationship to ISO 13485
QSR Management Review and Control (Subpart B)
Management and executive responsibilities
Developing a Quality Policy
Allocating adequate resources
QSR Design Control/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
Computerized system validation, including validating off-the-shelf software
QSR Corrective and Preventive Actions - CAPA (Subparts J, I, N)
Difference between correction vs. corrective action
Examples of preventive action
Evaluating CAPA sources
The Yin/Yang of Design/CAPA
FDA’s trending requirement
ISO 9001:2000 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 your 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 environment 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 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 FDA’s mindset
Inspection Observations and Reports
Consequences of non-compliance
Recent trends in FDA 483 observations
Practical suggestions surviving an inspection
This course is designed specifically to help device industry managers, engineers, QA/QC specialists, and regulatory affairs professionals improve their company’s compliance with FDA’s 21 CFR 820 Quality System Regulation.
The two-day QSR Compliance Basics training class offers engaging and informative exercises designed to help you apply the course concepts, terms and tools to real-world problems you’re likely to face back at your job. Throughout each exercise, you'll focus on documenting your actions and decisions to the satisfaction of an FDA or third-party auditor.
EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating its 20th year of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.
Since that time -- through hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.
"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems, May 2011)
Denise Dion, EduQuest
Denise Dion is a Vice President of Regulatory and Quality Services with EduQuest. She spent 18 years of her career with the FDA, where she served as an Office of Regulatory Affairs (ORA) headquarters’ authority on agency-wide inspections and investigations. She developed many of FDA’s inspection guidance and training materials, including serving as the primary editor of the Investigations Operations Manual (IOM). Denise 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, Denise provides regulatory guidance and regularly conducts facility audits to assess compliance with drug, medical device and biologics regulations. She also develops inspection preparedness training. She is the author of the EduQuest Advisory on “Using FDA’s Own Playbook to Prepare for Your Next Audit”.
"Denise is very engaging and is a great presenter on the topic."
"This was one of the best courses I have attended -- it was exactly what I needed!"
"These are great training courses which have already helped me with my job. Thanks very much!"
"The experience that Denise shared with great knowledge was great. The class was very informative. I truly enjoyed it."
"Informative and well-organized course. As a new RA/QA manager, this is a wonderful foundation for learning and helping my team. Thank you!"
"Well run and provided the depth I've been searching for."
"The instructor was truly fantastic. Her real-life experience, sense of humor and vast subject knowledge made this one of the best training classes I've attended."
"Denise is great. I really appreciate her knowledge, sharing of experiences, and overall demeanor."
“EduQuest has really helped us expand our quality system beyond ISO/IEC 17025 to the FDA requirements. We are much more confident in meeting our FDA needs! We are able to speak the language now as well. And we enjoyed Denise Dion’s style and stories. Even though everyone wanted to be told exactly how to do things, she was able to get across that we have to implement the regulations for ourselves and DOCUMENT why! ‘If it’s not documented, it doesn’t exist’ has become a constant quality slogan around here.” (Quality Manager, Blacksburg, VA)
QSR Compliance Basics:
Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation
Monday & Tuesday
September 18-19, 2017
Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC).
Day 1: 8:30 p.m. – 5:00 p.m.; Day 2: 8:30 a.m. – 5:00 p.m. U.S. Eastern Time
Continental breakfast, lunch and refreshments provided both days.
Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.
For sleeping room reservations, book your room online at the Hilton Garden Inn or call +1 (240) 566-1500.
Discounted sleeping rooms (single or double) for $122 per night (plus tax) are available until Friday, August 18, 2017. After August 18, 2017, sleeping rooms may still be available but likely will be at a higher rate.
To be notified when additional dates and locations are confirmed, subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.
1. Click on red button to download Registration Form, then fax to EduQuest at +1 301-874-6031 or email to EduQuest.
2. Or Email Info@EduQuest.net with any questions you may have about the course content or logistics.
3. Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time and charge your tuition to a major credit card
(Visa, MasterCard, American Express).
Tuition for the QSR Compliance Basics course is $1,595, including all course printed materials; ample time to ask your questions to the expert instructors; two lunches; two continental breakfasts; refreshments throughout the program; and a Certificate of Attendance to document your training to FDA and third-party inspectors as well as management.
Significant discounts also are available for teams of 2 or more from the same company who register together. Email Info@EduQuest.net for details or look over the Corporate Group Discount Rates here.
Combine the QSR Compliance Basics course with the two-day Design Control for Medical Devices course (offered immediately afterwards, on Wednesday and Thursday).
Save $593 on the combined tuition when you attend both courses. The combined tuition is $2,997, including hands-on training, all course materials, continental breakfasts, lunches, refreshments, and the opportunity to learn and interact with some of the top FDA compliance experts in the nation.
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031