Presented by
Management Forum
Process Validation for Medical Devices Training Course
This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.
5-6 June 2024
+ 15-16 October 2024 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Overview
Process validation is the means of ensuring and providing documentary evidence that processes (within their specified design parameters) are capable of consistently producing a finished product of the required quality.
This course has been designed to focus on process validation for medical devices. Day one will review the Regulatory and Quality Management System (QMS) links to process validation – essentially the need for validation. It will look at the preparation steps to be taken, including initial Risk Assessment, User Requirement Specifications (URS), the format of URS and include a practical review of bad versus good examples.
Day two of the course reviews the Installation Qualification, Operation Qualification and Performance Qualification process (IQ, OQ and PQ ) reviewing how this fits with regulatory needs and technical documentation. It will also look at the validation master plan and discuss continuous PQ and when that may be appropriate. Additionally, validation protocol content and execution, covering the recording of findings, managing excursions from required performance, plus other considerations will be reviewed.
Data integrity with an overview of the GAMPv (Good Automated Manufacturing Process) for software will also be included.
This is an excellent opportunity to receive a practical approach to Process Validation for Medical Devices.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
Benefits of Attending
- Gain a clear understanding of how Process Validation fits into the Quality Management System
- Understand the regulatory drivers for Process Validation
- Know the scope of FDA, EU and UK guidelines
- Realise significant business benefits by clarifying the key purposes of validation
- Receive a practical demonstration of document format and content expectations
Who Should Attend
- Validation specialists new to the medical device industry
- Quality and Regulatory specialists wanting to understand where Process Validation fits into compliance needs
- Process engineers
- Validation and Qualification managers
- Operations managers
The Process Validation for Medical Devices course will cover:
Why is Process Validaton Needed?
- Regulatory need - USFDA, EU, UK
- Quality need - fitting into the QMS
- Links for Design and Development
- Validation Policy, Validation Master Plan, Validation SOP
- Process Mapping Study
Where to Start?
- Risk assessment
- Direct, Indirect, or no impact to product quality
- Level of validation required
User Requirement Specification (URS)
- Review internal procedure.
- Format
- Approval
- Critical Process Parameters
- Critical Quality Attributes
Group Exercise - Review of an Existing URS
- Critique of format
- Critique of content
Workshop: URS
- Breakout groups to review and suggest improvement in the selection of URS
Factory Acceptance Test
- Definition and example
Site Acceptance Test
Facility Qualification
- HVAC
- Water
- Steam
- Compressed Gas
Computerized System Validation
- Electronic Signatures and Electronic Records
- IT Cyber Security
- Disaster Recovery & Business Continuity
- GAMP5
Cleaning Validation
- Prerequisites and example
Personnel Qualification
- Training
- Education
Analytical Method Validation
- Prerequisites and example
Supplier Assessment
- Supplier Audit & Qualification
Instalation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Regulatory need? How will this fit with Technical documentation?
- Risk-based commissioning and qualification
- Quality Need? What drives this from the QMS?
- Links for Design and Development
- Validation Master Plan
- Continuous PQ – What and when?
Validation Protocols
- Review internal procedure
- Example of good practice with links to conformity assessment requirements
- Sampling plan requirements
Valdiation Protocol Execution
- Recording of findings
- Managing excursions from required performance
- Data Integrity
- Considerations
- Approval
Change Control, Revalidation & Requalification
- Risk-based change control
- When to requalify, how to revalidate?
Group Exercise: Review of Exisiting Validation Plan & Report
- Critique of format
- Critique of content
Workshop: Validation Plan & Report
- Breakout groups to review and suggest imporvement in Validation Protocol
Mustafa Edik
Mustafa Edik is an Independent GMP Consultant and Auditor.
After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
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
5-6 June 2024
Live online
09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 14207
- GBP 1,099 1,299
- EUR 1,579 1,859
- USD 1,786 2,098
Until 01 May
- 2 days 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
15-16 October 2024
Live online
09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 14208
- GBP 1,099 1,299
- EUR 1,579 1,859
- USD 1,786 2,098
Until 10 Sep
- 2 days 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; and apply only when booking multiple delegates on the same date.
Switzerland
- Surgical Fusion Technlogies GmbH
United Kingdom
- Kindeva Drug Delivery
