process validation & verification (v&v) for medical devices
Post on 19-Aug-2014
2.324 Views
Preview:
DESCRIPTION
TRANSCRIPT
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Process Validation and Verification
Rina Nir
Rina.Nir@RadBee.comwww.RadbeeQMS.com
105/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 205/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Process Validation and Verification
From Prototype To ProductSix Focus Areas
305/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Consistent Output
405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Controlled Process
505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 05/2014
Erez Adiv, MedicSenseNeomi Katz, Pharma Quality EuropeChris Monchinski, Automated ControlSun Kim, QbD WorksMarkus Roemer, Comes Compliance ServicesKirsi Rosenqvist, MedtentiaLine Szlamka, 4Echo, member of MEPY BENELUXOne anonymous (off-record)
Interviewees:(In alphabetic order)
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
GET YOUR CEO COMMITTED#1
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Management Commitment?
Quality
We stand for quality.
We live our quality system according to ISO 9001:2008 and ISO 13485:2012.
www.<NAME>.com/quality
805/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Management Commitment!
Using photo: http://upload.wikimedia.org/wikipedia/commons/1/1d/Auguste_Rodin-The_Thinker-Legion_of_Honor-Lincoln_Park-San_Francisco.jpg by Yair Haklai .Using: Entypo Font
905/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.comhttp://www.imdrf.org/documents/doc-ghtf-sg3.asp
1005/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.comhttp://www.imdrf.org/documents/doc-ghtf-sg3.asp
1. Body - 11 pages2. Intro to statistics – 10 pages3. Example – 12 pages
1105/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Culture Change
1205/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Culture Change
1305/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
What Could Go Wrong?
1405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 1505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Affected pumps were manufactured in 1998.Recall issued in 2014!
1605/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
ESTABLISH AN INTERDISCIPLINARY TEAM
# 2
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Where Magic Happens
1805/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
What variability do we allow?
1905/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
What Risk Exists If Parameters Are Out Of Range?
DiameterComposition
CurvatureSoaking liquid
Etc.
2005/2014
Are They All Equally Important?
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Consistently Producing A Stunning Product
2105/2014
The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Requires Multidisciplinary Expertise
2205/2014
The Free4 Concept Wheelchair. Designer: Mr. Markus Ofner, FH JOANNEUM GesmbH
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
START EARLY# 3
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 2405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 2505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Wishful Thinking
2605/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
A More Practical Approach
2705/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
V Model Planning
05/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
KNOW YOUR SUPPLIERS AND SUBCONTRACTORS
#4
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Not Equal Partners
3005/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Contractor Selection
• According to level of risk (criticality).• Expertise.• ISO-13485 for this particular type of process.• Certification by a reputed body.• Serves big companies.• Pre-contract audit.• Quality agreement.
3105/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Quality Decision
3205/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Quality Decision
3305/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Quality Agreement
• Quality decision details.• Certification Of Compliance and other forms.• Quality process commitments (V&V).• Forbid non-authorized modifications.• Record retention (with Escrow agreement).• Audit right.
3405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Where Magic Happens
3505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
MAP YOU PROCESS#5
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Know Your Process
“If you ask people to describe their process, very often different people will describe it differently…. There is no consensus about how the process is.They have many work instructions but not a single schema which describes the process.”
Markus Roemer
3705/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Process Map
3805/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
“Obtaining a process that consistently conforms to requirements requires a balanced approach using both mistake proofing and variation reduction tools”
GHTF Guideline
3905/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Poka-Yoke
No way to get it wrong
4005/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
MANAGE THE MANUFACTURING RECORDS
#6
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Data Flow Complements Your Process Map
4205/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
One FDA Investigation Report
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4305/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
A Thorough Investigation
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf
4405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Controlling Computerized Systems
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf
4505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Paper-Forms and Back-Dating
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4605/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Do Not Use Sticky Notes!
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf4705/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
Using Excel In Manufacturing
4805/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
When Subcontracting
• Include records related commitments in the Quality Agreement:– Access– Retention– Escrow
• Include records investigation in your audits.
4905/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
CONCLUSION
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com
1. Gain CEO commitment.2. Establish a multidisciplinary team.3. Start Early.4. Know your suppliers and sub-contractors.5. Map your process.6. Manage the manufacturing records.
5105/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Rina.Nir@RadBee.com 05/2014
Erez Adiv, MedicSenseNeomi Katz, Pharma Quality EuropeChris Monchinski, Automated ControlSun Kim, QbD WorksMarkus Roemer, Comes Compliance ServicesKirsi Rosenqvist, MedtentiaLine Szlamka, 4Echo, member of MEPY BENELUXOne anonymous (off record)
Interviewees:(In alphabetic order)
Rina.Nir@RadBee.comwww.RadbeeQMS.com
top related