Team Training Workshop: Agile, Agility and Compliance in FDA and ISO Regulated Environments
Team Training Workshop: Agile, Agility and Compliance in FDA and ISO Regulated Environments
Learn how to apply agile values and principles during product development while complying with FDA, ISO and other regulatory requirements.
Duration: 14 hours
Audience: All product team members
Course format: Group live online or onsite workshop
(for individuals, an e-learning format is available)
Certified Digital Open Badge: Agile Professional - REGULATORY AGILIST
Regulatory environments make the implementation of an agile operating model challenging. This workshop lets participants understand and tackle those challenges. Specific attention is paid to quality systems, design controls, and risk management. As a case, we look at the medical devices but principles and techniques can be applied to any regulated industry sector.
WORKSHOP STRUCTURE
Block 1: Regulatoriy Context, Agile and Agility
· Regulatory goals for product development
· FDA/EMA classes and controls
· Relevant standards and guidance documents, and how they relate
· Servant leadership & coaching
· Case: the FDA and Agile
Block 2: QSR and Design Controls
· Quality System Regulations and QSM
· FDA QSR subsystems
· Design controls
· Using design controls in an agile SDLC
Block 3: Mapping IEC62304 Processes onto an Agile SDLC
· IEC62304 regulatory processes
· Regulatory system requirements
· IEC62304 process activities with stories and increments management
· From enterprise agile to business agility
Block 4: Agile Risk Managment in line with ISO14971
· ISO14971 risk management process and agile
· Risk analysis and evaluation
· Risk controls
· Residual risks and benefit-risk considerations
Block 5: Agile Best Practices and Tools to Improve Compliance
· Aligning agile principles and value creation with regulatory interests
· Incremental compliance with layers and cycles
· Specific agile mechanism to support compliance
· Overcoming agile challenges in regulatory environments
DIGITAL CERTIFICATION BADGE
WHAT IS INCLUDED?
✓ Attendance at the training event
✓ Courseware: instruction materials
✓ Resources: Agile Working toolkit
✓ Course Certification
✓ 12 months of Q&A support
ANY DOUBTS OR QUESTIONS?
Please ask agileXL Academy
RELATED TEAM WORKSHOPS
â—¼ Executive Strategies for Enterprise and Business Agility
â—¼ Agile Ways of Working for Teams
RELATED E-LEARNING
â—¼ Agile in Regulated Environments
TRAINING VENUES
Our live online and self-paced formats permit anybody to participate regardless of your location.
In addition, we offer in-company training in any location worldwide.
Venues for public training are located in the following cities:
Seattle, San Francisco, Denver, Chicago, Boston, New York, Austin (USA) · Vancouver, Toronto, Ottawa, Montreal, Halifax (Canada) · Mexico City, Monterrey (Mexico) · Rio de Janeiro, Sao Paulo, Brasilia (Brazil) · Buenos Aires (Argentina) · Santiago (Chile) · Vienna, Montevideo (Uruguay) · Stockholm, Gothenburg (Sweden) · Copenhagen (Denmark) · Dublin, Cork (Ireland) · London, Manchester, Glasgow, Brighton (UK) · Paris, Lille, Toulouse, Lyon, Montpellier, Bordeaux, Nice (France) · Amsterdam, Rotterdam, Utrecht, Eindhoven (Netherlands) · Brussels, Antwerp (Belgium) · Berlin, Munich, Frankfurt, Hamburg (Germany) · Helsinki (Finland) · Tallinn (Estonia) · Vilnius (Lithuania) · Riga (Latvia) · Zurich, Geneva (Switzerland) · Vienna, Innsbruck (Austria) · Prague (Czech Republic) · Budapest (Hungary) · Warsaw, Kraków (Poland) · Milan, Rome (Italy) · Barcelona, Madrid, Valencia, Málaga (Spain) · Lisbon, Porto (Portugal) · Moscow, St Petersburg, Novosibirsk (Russian Federation) · Casablanca (Morocco) · Tunis (Tunisia) · Cape Town, Johannesburg, Durban (South Africa) · Nairobi (Kenya) · Lagos (Nigeria) · Tel Aviv (Israel) · Beirut (Lebanon) · Riyadh, Jeddah (Saudi Arabia) · Abu Dhabi, Dubai (UAE) · Doha (Quatar) · Delhi, Pune, Mumbai, Hyderabad, Bengaluru, Chennai (India) · Bangkok (Thailand) · Kuala Lumpur (Malaysia) · Singapore · Jakarta (Indonesia) · Ho Chi Minh City (Vietnam) · Seoul (South Korea) · Beijing, Shanghai (China) · Hong Kong · Tokyo, Osaka (Japan) · Sydney, Melbourne, Brisbane, Perth (Australia) · Auckland, Wellington (New Zealand)