AAMI - QS Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

  • 07 Sep - 11 Sep 2020
  • Royal Marine Hotel & Spa in South Dublin
  • Dublin / Ireland

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today’s global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and 14971.

Day 1 08.00 - 17.00

  • FDA Inspectional Approach-QSIT
  • Overview & Management
  • Document Controls & Records

Day 2 08.00 - 17.00

  • Design Controls

Day 3 08.00 - 17.00

  • Acceptance Acivities
  • Production & Process Controls

Day 4 08.00 - 17.00

  • Production & Process Controls
  • Monitoring & Feedback

Day 5 08.00 - 12.00

  • FDA QSIT overview
  • Medical Device Single Audit Program

 

  • The course and exam are essential requirements for quality and system experts.
  • Instruction is targeted to professionals directly involved in meeting FDA's Quality System requirements or those who are ultimately responsible for compliance.
  • Past course attendees have included representatives from industry, quality systems consulting and the FDA

Benefits of Attending This Event

  • World renowned course being held locally
  • Opportunity to expand your organisations knowledge of quality systems regulations
  • Opportunity to discuss interpretations with other medical device manufacturers
  • Networking opportunity to bring multiple divisions of your organisation together locally
  • Siginificant cost and time savings

 

Course Highlights

  • Intensive 4 1/2 day program developed by the FDA and quality system experts
  • Covers all aspects of the FDA quality systems requirements
  • World class faculty
  • Mandatory training for FDA Accredited Persons Program
  • All participants recieve a copy of 'The Quality System Compendium' (The bible on interpreting QS Regulations)

Optional Exam

  • An exam to test mastery of the course materials and ability to correctly interpret the Quality System Regulation will be available to all participants online for 2 weeks following the end of the program.

Course Program - Day 1

07.30 Registration
08.00 Introductions and Welcome
08:40 Overview & Definitions
Objections of this module are to:
1. Provide a general overview of the Quality System Regulation
2. Explain the intent of the QS requirements
3. Define who is subject to the QS requirements
09.30 Networking Break
09.45 Management. Includes exercise on quality policy
Objections of this module are to:
1. Explain the requirements of a Quality System
2. Describe the flexibility inherent within the Quality System Regulations
3. Describe the management responsibilities for the quality policy
12.00 Networking Lunch
13.00 Document Controls
Objections of this module are to:
1. Describe the elements of an adequate document control process
2. State where and how documents are to be maintained and for how long
3. Discuss factors related to record liability
4. State which types of records FDA does not inspect during a routine inspection
5. State the purpose of the Quality System Record (QSR)
14.30 Networking Break
14.45 Case Study: Quality Audit
Objections of this case study:
1. During this case study you will apply the knowledge you have learned in the previous sections.
15.50 Networking Break
16.00 FDA Organisation and Inspections
Objections of this module are to:
1. Review the FDA organisation and responsibilities for medical devices
2. Understand device classes and product classifications
3. Review the FDA inspections requirements, procedures and regulatory follow-up
4. Review current FDA Warning Letter process
5. Review current FDA data analysis of 483 observations and Warning Letters
17.00 Close

Course Program - Day 2

08.00 Introduction for the day / Q & A
08:30 Design Control Overview, General Requirements and Planning
Objections of this module are to:
1. State the types of devices subject to design controls
2. Explain when in the product development process design controls are required
09.30 Networking Break
09.45 Design Input, Risk Analysis. Includes Exercise on Design Input
Objections of this module are to:
1. Define design input and to explain what makes design inputs "appropriate"
2. Discuss the mechanisms for addressing incomplete, ambiguous and conflicting requirements
3. Understand the goal of risk management
11.10 Networking Break
11.20 Design Outputs and Design Review
Objections of this module are to:
1. understand the requirements for design outputs
2. Understand the requirements for the performance of deisgn reviews
12.00 Networking lunch
13.00 Design Verification & Validation, Design Transfer, Design Changes
Objections of this module are to:
1. Understand design validation requirements
2. Understand the difference between design verification and design validation
3. Understand the requirements for design transfer
14.30 Networking Break
14.45 Case Study: Design Changes
For this case study you will implement the knowledge you have learned in the previous module in assessing design changes
15.50 Networking Break
16.00 Software validation
Objections of this module are to:
1. Define the software validation requirements for product software
2. Provide an introduction to the software validation concepts
16.30 Design History File
Objections of this module are to:
1. Understand the requirements for the design history file (DHF)
2. Discuss methods of maintaining a DHF
17.00 Close

Course Program - Day 3

08.00 Introduction for the day / Q & A
08:30 Purchasing Controls
Objections of this module are to:
1. Describe the elements that must be addressed for purchasing controls
2. Discuss the types of controls that a manufacturer should ensure over any product or service obtained from suppliers
09.30 Networking Break
09.45 Acceptance Activities
Objections of this module are to:
1. Describe how identification, traceability and acceptance status are interrelated
2. Describe the elements that must be addressed for statistical techniques and sampling plans
11.00 Networking Break
11.10 Class Exercise: Purchasing Controls
For this exercise you will define what purchasing controls are suitable for a medical device manufacturer
12.00 Networking lunch
13.00 P&PC: Production and Process Control
Objections of this module are to:
1. Explain when process control procedures are required
2. Describe when contamination controls are necessary
3. Provide examples of manufacturing materials
4. Explain requirements applicable to automated processes
14.30 Networking Break
14.45 Case Study: Equipment Qualification
For this case study you will define the qualification approach to different pieces of equipment
15.50 Networking Break
16.00 P&PC: Process Validation
Objections of this module are to:
1. Be able to determine which processes should be validated
2. Describe requirements for addressing changes to validated processes
17.00 Close

Course Program - Day 4

08.00 Introduction for the day / Q & A
08:30 P&PC: Inspection, Measuring & Test Equipment
Objections of this module are to:
1. State the types of instruments that must be controlled under a calibration system
09.00 P&PC: Labeling and Packaging
Objections of this module are to:
1. State the requirements associated with labeling
2. State the requirements for device packaging and shipping containers
09:30 Networking Break
09.45 P&PC: Handling, Storage, Distribution & Installation
Objections of this module are to:
1. Describe storage area / stockroom controls
2. Explain how to prevent adverse effects during product storage
3. State the requirements for distribution records
4. State the provisions of the installation requirement and explain their purpose
10.30 Monitoring: Nonconforming Product
Objections of this module are to:
1. Describe the controls and investigation requirements for noncoforming product
2. Describe the requirements for rework of nonconforming product
11:00 Networking Break
11.10 Monitoring: Complaint Files
Objections of this module are to:
1. Define "complaint"
2. Briefly discuss the link between 820.198 and 21 CFR 803 Medical Device Reporting
12.00 Networking lunch
13.00 Exercise: Compalint Handling
For this exercise you will apply the knowledge you have learned in the previous module and assess various complaint files
13.55 Monitoring: Servicing
Objections of this module are to:
1. Explain when services requirements are applicable
2. Describe the relationship between service reports, complaint handling and CAPA
14:15 Networking Break
14.30 Monitoring: Corrective and Preventive action
Objections of this module are to:
1. Identify possible sources of quality data
2. Explain what is meant by "Closed Loop" corrective action
3. Discuss the link between CAPA and management review
15.20 Exercise: CAPA
For this exercise you will apply the knowledge you ahve learned in the previous module and assess various CAPAs for compliance with the QS Regulations
16.30 Conclusion / General Q & A
17.00 Close

 

Course Program - Day 5

 

MDSAP – 2 hours
FDA Inspectional Approach/QSIT – 2 hours



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Standard Ticket

€3295
  • 3rd Edition of AAMI compendium included
  • Free wifi at the conference
  • Conference plus lunch, coffee/snacks
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