Presented by
Management Forum
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Training Course
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
28 November 2023
from £299
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
- An Introduction to the Medical Device Regulation
- Introduction to the In-Vitro Diagnostic Regulation (IVDR)
- The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
- An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
- Managing Competence within the Medical Device Industry
- An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
Course Overview
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including maintaining this state for a defined period of time. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriate and stable sterile barrier system is important and expected when demonstrating conformity with the regulations.
These requirements are supported by a series of standards for maintaining sterility over time with appropriate sterile barrier systems.
This course provides an introduction to these regulatory requirements, as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Benefits of Attending
- Gain an overview of the types of sterile barrier systems used for medical devices
- Understand the principles of sterile barrier system validation
- Learn the regulatory requirements for sterile barrier systems and how to comply
- Gain an awareness of the ISO 11607 series of standards
Who Should Attend
- Quality Management System (QMS) specialists
- Quality, Packaging and Validation Engineers
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
Please note that delegates will require access to a copy of ISO 11607-1 to gain the most from this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 11607-1 - https://www.iso.org/standard/70799.html
This standard is also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
The An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices course will cover:
The ISO 11607 Series of Standards
- Background and reference to EN 868 and AAMI TIR22
- Definitions
- Types of packaging systems
- Packaging materials
ISO 11607 Part 1
- General requirements
- Material requirements
ISO 11607 Part 1 (continued)
- Designing a sterile barrier system
- Packaging system performance and stability testing
ISO 11607 Part 2
- Sterile barrier system manufacturing
- Equipment validation
- Process validation
- Process control and ongoing monitoring
Annette Callaghan
Sterile Management Systems
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Book An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
28 November 2023
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14239
- GBP 299 349
- EUR 429 499
- USD 501 579
Until 24 Oct
- 3 hours of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
