Embed Size (px)
DESCRIPTION
Six focus areas to drive a succesful process V&V. Presentation from the MedTeck UK 2014 Conference.
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
Process Validation and Verification
Rina Nir
105/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
[email protected] 205/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
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.
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.
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.
[email protected] 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.
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.
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.
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.
[email protected]://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.
[email protected]://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.
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.
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.
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.
[email protected] 1505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
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.
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.
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.
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.
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.
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.
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.
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.
[email protected] 2405/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
[email protected] 2505/2014
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CONCLUSION
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.Photos are copyrighted as per their respective license.
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.
[email protected] 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)
