QSR Compliance Basics:
QSR Compliance Basics:
Complying with FDA's Medical Device 21 CFR 820
Quality System Regulation
The scope of FDA’s Quality Systems 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, 27 medical device companies 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 Systems 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 1- ½ 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 directly from former FDA device officials and industry advisors
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 EduQuest’s QSR Compliance Resource CD with electronic copies of FDA’s latest quality regulations and guidance
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
Course Curriculum –
Day 1: 8:30 a.m. – 5:30 p.m.; Day 2: 8:30 a.m. – 12:30 p.m.
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
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: 2000 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 Control/System Development (Subpart C)
Tools for design control
Research vs. design
Design verification and validations
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 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
Denise Dion, EduQuest 18 years as FDA investigator and trainer and co-editor, FDA Investigations Operation Manual (IOM) |
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 was very obliging and answered all my questions in depth, so I definitely feel more confident in my new role as CAPA specialist. She [also] did an excellent job of explaining good CAPA reporting. ” (Effective and Compliant CAPA Systems course, July 2009, Dublin, Ireland)
“Denise was excellent!” (Design Control for Medical Devices course, March 2011, Anaheim, CA)
“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) |
Who should attend:
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.
2012 Course Schedule:
Day 1: 8:30 a.m. – 5:30 p.m.; Day 2: 8:30 a.m. – 12:30 p.m.
Lunch on Day 1 and refreshments provided through program.
October 16-17, 2012: Hilton Garden Inn Hotel, Frederick Maryland (near Baltimore and Washington, DC). www.frederick.stayhgi.com. Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.
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, contact ClarenceDanielson@EduQuest.net.
Tuition for the QSR Compliance Basics course is $1,495. Immediately following the course, EduQuest offers a 16-hour course on Design Control for Medical Devices: Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing.
Save nearly $500 when you attend both courses. The combined tuition is $3,000, including hands-on training, all course materials, lunch, refreshments, and the opportunity to learn and interact with some of the top FDA compliance experts in the nation.
Class registration is easy. To enroll or get more details:
(download
Registration Form for October 16-17, 2012, course in Frederick, MD)
Or Email Martin at Info@EduQuest.net
Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time
Register 5 students for the price of 4. Significant discounts also are available for teams of 2 or more from the same company who register together.
Combine this course with the 16-hour Design Control for Medical Devices course (offered on Wednesday afternoon through Friday morning) and save nearly $500 on the combined course tuition.
RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031