The learning cycle
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I’mwilling tolearn I
thinkI knowwhat I’mdoing
I
feel confident
I thoughtI knewit, but I don’t
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Know what you need to deliver
Ask AskAsk! 9 Knowledge is power but sharing is even more powerful 10 LicensedtoAttendeesofRQA2022only
Tools 11 FDA Warning letters Guidelinesand regulations QA websites/meetings Governmental blogs EMA Scientific Advice Artificial Intelligence Q‐Data Begin with the end in mind and know how to get there 12 LicensedtoAttendeesofRQA2022only
Drug Development Road Map 13 Pre‐Approval Approval Post‐Approval Clinical Phase I Full Scale Pilot Scale Phase III Phase II RA Dossier Approval Maintenance Commercial Scale Post‐Market Surveillance Phase IV Non clinical Lab Scale Production Common Technical Document 14 LicensedtoAttendeesofRQA2022only
Keep on moving, even if things get tough 15 16 LicensedtoAttendeesofRQA2022only
17 • • • 18 “I
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don’tunderststandthe
regulations”
“We have alreadyhad somanynew initiativesthisyear. I reallydon’t have time todo mycoreduties…let aloneimprove!”
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“No oneever givesme support whenI want todo somethingnew”
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“I do notreallyknowourquality level at present sohowcanI improve?”
“We justcannotfinanceany improvementsat present.”
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Research and development
Obstaclesandchallenges:
• Lackof awareness of theimportanceof theworkforlater stages in development.
• Lackof data integrityknowledge.
• Researcherswant toknoweverything.
Solutions:
• Educateresearchersanddeveloperson theimportanceof theirworkand next steps.
• Providestructurefordata andtraining on data integrity.
• Focus on whatmatters, but embraceinnovation.
Small start‐up companies
Obstaclesandchallenges:
• Lackof funding.
• Lackof expert knowledgein specificareas.
• Over complicatedQMS.
Solutions:
• EMA fee reductionsandgrantsforSMEs.
• Growyournetwork
• Make useof EMA ScientificAdvice.
• Keep theQMS simple. Lessis more.
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Large global internationals
Obstaclesandchallenges:
• Global qualitysystems (does onesizefit all?).
• Overloadon new systems.
• Lackof sharingof information (“what’sdevelopedin theUK staysin theUK”).
• Oversharing of information (theemail waterfall!).
• Multiple approvalsleadingtolong start‐uptimes.
• Culturaldifferencesin theworkforce.
• Keepinglong‐term staffmotivated.
Large global internationals
Solutions:
• Don’tbreak whatisn’tbroken! EmbracetheQMS thathas proven to work.
• Assesstherisk/benefits beforeintroducingnew systems.
• Developmulti‐disciplinaryteams (includeregulatoryaffairs).
• Emails: thinkbeforeyousend!
• Embracethebenefits of culturaldifferences.
• Buddy up experiencedandlessexperiencedstaff.
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Quality by Design (QBD)
QBD canbeapplieduniversallyacrossallGXPs
• Understand yourcriticalphases(GLP)
• Understand yourcriticalqualityattributes, processesandparameters (GMP)
• Understand criticaltoqualityfactors (GCP)
• Control whatyoucanandknowwhatyoucan’t
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Monitoring Process and Product Quality 28 LicensedtoAttendeesofRQA2022only
What are the risks and benefits? 29 30 “Ifa thingis worthdoing itis worthdoingwell!” Chinese proverb LicensedtoAttendeesofRQA2022only
Product and Process Quality Monitoring
Staff training
Staff training
•Product quality
•Staffpass witha gradeof 80% or higher
•Processquality
•At least90% of staffpass per year
United we stand…divided we fall
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The battle for improvement
• A well thoughtthroughplan willwin thebattle
• Never go italone, youwillneedsupport frommany sides
• Collaborateon alllevels (includethesoldiersandnot justthegenerals)
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Implementing improvement 34 LicensedtoAttendeesofRQA2022only
Change control
• Reducesthechancesof unnecessarychanges.
• Helpsmanage risk.
• Knowwhoneedstoapprovechange.
• Consider:
• Are therelegalrestrictions?
• How willthechanges impact thepresent processes/products/services?
• How willthechanges impact staff?
• Whatresources are requiredforthechange?
• Will thechange bringnew risks, problemsor new opportunities?
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“Eachimprovementrequiresa change, but notallchanges lead toimprovement!”
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Improvement plans
• Knowyourobstaclesandchallenges.
• Don’tmake theproject toolong/toobig.
• Includeyourinfluencers.
• Includeclients (external/internal).
• Set up a communicationplan.
• UseSMART goals todefinesuccess.
• Indicatehowsuccesswillbemonitored.
• Includefollow‐up verification.
• Who will be involved?
• What will be measured/assessed?
• What reports are needed?
• Who will assess/review the reports?
• How will the outcome be communicated?
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Follow‐up verification 38
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Giveencouragement • Communicate the outcome • Learn from the process • Reward staff for their input 39 Celebrate Success 40 LicensedtoAttendeesofRQA2022only
Whendevelopingquality, understandwhat’simportant, knowyourchallengesandhow todeal withthem.
What will this baby be doing in 30 years time?
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THANK YOU FOR JOINING THE SESSION RQA conference 9‐11 November 2022 Quality RE:UNITED Speaker : Christine Mitchell ChrisalisQAdvice www.chrisalisqadvice.com Christine.Mitchell@chrisalisqadvice.com 43 Questions? LicensedtoAttendeesofRQA2022only
