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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 Martin Browning, co-author of FDA's QSR -- the Quality System Regulation
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 co-author of 21 CFR Part 820 and a senior policy-maker and expert field investigator for 22 years at the U.S. FDA
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 more than 20 years 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)
President and Co-Founder,
Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).
At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other organizations.
"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 the instructor 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."
“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. Even though everyone wanted to be told exactly how to do things, EduQuest 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
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.
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