Advanced Stability Testing of Pharmaceuticals

www.glceurope.com

Online MasterClass 26-29 October, 2021

Advanced Stability Testing of Pharmaceuticals

MasterClass

Dr. Manuel Zahn

Learning outcomes:

• Theimpactofthermalenergyandhumidityondegradation• Whatstabilitydataarerequiredtogainregulatoryapproval• Thesmartselectionoftheoptimalpackagingmaterial• Howtodemonstratesensitivitytolight• Thedesignofforceddegradationstudiestostressthesubstance• Thespecificsofbiopharmaceuticalsandbiosimilars• Howtodesignasmartstabilityprogrammeforglobalmarkets• Statisticstopredictashelf-lifebasedonshort-termstabilitydata• Whatkindofstabilitydataarerequiredtosupportshipmentandstorage?• Theopportunitiesforreducedstabilitystudies

https://www.linkedin.com/in/manuelzahn/

Advanced Stability Testing of Pharmaceuticals MasterClass

[email protected] +36 1 848 0515www.glceurope.com

26-29 October, 2021Online MasterClass

Who Should Attend?

eVent IntRoduCtIon

The course will provide practical advice for chemists and pharmacists in the pharmaceutical

industry as well as in regulatory agencies.

• StabilityManagers/Staffs

• FormulationDevelopmentScientists

• QA/QCProfessionals

• AnalyticalDevelopmentScientists

• RegulatoryAffairsPersonnel

• CMO/CROScientists

Thispublictrainingcoursewillcoverthescientificprinciplesofchemicalandphysico-chemical

degradation of active substances and pharmaceutical products as well as the regulatory

requirementstoestablisharetestperiodorshelf-life.

https://glceurope.com/




manuel is Managing director at 3R Pharma Consulting Gmbh (www.3rpc.com) since 2008. Prior

to founding his consultancy company, he spent almost 30 years in the pharmaceutical industry,

mainly in Regulatory CMC, inter alia at AstraZeneca R&d in Sweden and Germany, and at Knoll

AG (now AbbVie) in ludwigshafen. he studied chemistry at the university (th) Karlsruhe.

dr. Zahn has been a member of the ICh expert Working Group developing the ICh

Stability Guidelines (1991-2003) and the ICh Ctd Guideline M4-Q (1997-2001). From 2001

to 2005, dr. Zahn represented the IFPMA, when the ASeAn Stability Guideline has been

developed. As a Who temporary Advisor, he has been involved in developing the revised

Who Stability Guideline released in 2009.

over 30 papers in journals and textbooks have been published since 1978, and presentations

delivered at many international conferences and training courses since 1988.

Meet the Trainer:

Dr. Manuel Zahn


https://3rpc.com/regulatory-affairs.html

https://www.linkedin.com/in/manuelzahn/




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Basicprinciplesofstabilitytesting-PartI

• The impact of thermal energy on chemical degradation• Arrheniusequation/Arrheniusplot• Calculationofthedegradationrate• Establishinga“DesignSpace”forstorage conditions• MeanKineticTemperature(MKT)

Systematicapproachtostabilitytesting

• Releasevs.shelf-lifespecification• ICHStabilityGuidelines• StabilitytestingprogrammesfordrugproductaccordingtoICHQ1A

• Teststhatshouldbeperformedand intervals;

• Robuststabilityindicatingmethods;• Howtoproceediflife-cycleofmethod

isnotrobust?• Massbalance;• Samplesthatneedtobeincludedfor

stabilitystudies:ProcessValidation batches

• Reducedstabilitytesting:Bracketing&Matrixing(ICHQ1D)• In-usestabilitytestingoforalandinjectable products• Ongoingstabilitystudies• OtherspecificEUStabilityGuidelines• Bulkstability/holdingtime

Photostability studies (icH Q1B)

Stabilitystudiesforpeptidesandproteins

• ICHStabilityGuidelinesforBiopharmaceuticals(ICHQ5C)• Specificstability-indicatingtests• Degradationanddecomposition• Designofstabilitystudiesforbiopharmaceuticals• Requirementsincaseofchanges(ICHQ5E)

ForcedDegradationStudies(StressTesting)

• Purposeofstresstestingvs.testingatacceleratedconditions

• Methodsusedtoartificiallydegradesubstances• Methodsusedtoartificiallydegradesubstances

StabilityTestingforZoneIIIandIVTerritories(WHOStabilityGuideline)

• TheClimaticZoneConcept• Meteorologicaldata• Consequencesforlong-termtestingconditions• GlobalTestingDesign

Basicprinciplesofstabilitytesting-PartII

• The impact of humidity• Partialandsaturatedwatervapourpressure• Relativehumidity• Permeabilityofpackagingmaterialfor water vapour• TheIsoconversionalMethod(ASAP)• Howtoselecttheoptimalpackagingmaterial?

ConnectingtotheonlineMasterClass ConnectingtotheonlineMasterClass

All dates and times are expressed in UTC/GMT+2 on the Agenda (CET Time Zone)





day 3 day 4

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Let’sgrabacoffee

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11:30

12:20

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Statisticalanalysisofstabilitydatasupportingshelf-lifeestimation

• Calculationofaregressionline• GenerationofANOVATables• 95%ConfidenceLimit

ReducedStabilityStudies/SpecificTopics/GMPAspects

• Reducedstabilitystudiesforgenerics• Stabilitystudiesforvariationsand changes after approval• Modificationoftheshelf-lifespecification after approval• ImpactofchangesonregulatoryactivitiesintheEU(TypeIA,IB,II)

Specificquestions:

• Leachablesandextractables• ContainerClosureIntegrity(CCI)testreplacingsterilitytestofstabilitysamples

GMPaspectsofStabilityStudies

• Qualification,calibrationandmaintenanceofstabilitychambers• Managementofexcursions

Feedback/Evaluationsession

Stabilitystudiessupportingshipmentand storage

• Thelegalframework(GDP&more)• Monitoringshipmentandstoragecondition• Calculationofremainingshelf-lifeaftertemperatureexcursions

DetectingOOT/DealingwithOOSresultsduringstabilitystudies

ConnectingtotheonlineMasterClass ConnectingtotheonlineMasterClass

All dates and times are expressed in UTC/GMT+2 on the Agenda (CET Time Zone)





Upcoming Events

FINANCIAL EVENTS

• Fraud Preven� on, Detec� on and Inves� ga� on MasterClass

• Eff ec� ve Remote Internal Audi� ng MasterClass

• Facing Risks in Business MasterClass

• Fixed Income Por� olio Management MasterClass

• The Future of Internal Audit MasterClass

• Advanced Enterprise Risk Management MasterClass

September, 2021

September, 2021

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November, 2021

August, 2021

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September, 2021

September, 2021

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October, 2021

October, 2021

October, 2021

October, 2021

October, 2021

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November 2021

August, 2021

September, 2021

September, 2021

PHARMACEUTICAL EVENTS• Analysing and Dra� ing Commercial Contracts in Life

Sciences MasterClass

• VBA & Innova� ve Contrac� ng in Pharma MasterClass

• Pharma Contract Dra� ing MasterClass

• A Stakeholder Engagement Approach to Clinical Trials

MasterClass

• Pharma Mergers and Acquisi� ons MasterClass

• Advanced Precision Medicine MasterClass

• Pharmacovigilance on the Internet and Social Media

MasterClass

• Advanced CMC MasterClass

• How to Submit Varia� ons in Europe MasterClass

• Advanced Pharma Root Cause Analysis MasterClass

• Blockchain in Pharmaceu� cals Masterclass

• Unlocking the Poten� al of Cell and Gene Therapies

MasterClass

• Cri� cal Quality A� ributes of Recombinant Proteins

for Therapeu� c Use MasterClass

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• Mee� ng the In Vitro Medical Devices Regula� on

MasterClass

• Advanced Nanotechnology in Medicine MasterClass

• Advanced Genome Edi� ng MasterClass

• US Healthcare & Smart Pharma Packaging –

Regula� ons & Technical MasterClass

• Synthe� c biology & Biopharma – a unique pla� orm

for growth and sustainable future MasterClass

• Risk Based Monitoring - During & Beyond Covid

MasterClass

• Advanced CMC MasterClass for the US Market

• Advanced CMC MasterClass + How to Submit

Varia� ons in Europe MasterClass

HUMAN RESOURCES EVENTS • Digitaliza� on Compensa� on & Benefi t Processes MasterClass

• Manage the Annual Salary Review MasterClass

CROSS INDUSTRY EVENTS • H&S Legal Compliance and Leadership MasterClass

About GLC

Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business.Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources.Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest know-how’s and benchmark yourself higher against the competition while enjoying a 5 star environment.

What is it?

• no travel or logistic expenses for the team (we deliver it at your facilities)

• Maximize RoI with a depth tailored content accordingly to your corporate needs

• 360 degrees GlC learning experience – Individual pre-questionnaire for each participant, several case studies and post training diagnose with participants

• Maturity assessment for the team during the preparation of the course

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Documents

Advanced Stability Testing of Pharmaceuticals