BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Eventin//Event Calendar//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
BEGIN:VEVENT
UID:0c99e5a71cf183e8891a0e9f42b8140e@mivado.com
SUMMARY:Advanced Biopharma Stability Program Design
DESCRIPTION:Advanced Biopharma Stability Program Design\nTwo-Day Training\n
 Overview\nThis two-day advanced training is designed for professionals in t
 he biopharmaceutical\, pharmaceutical\, and medical device industries who a
 re involved in stability program development. The program will cover key re
 gulatory requirements\, best practices for study design\, data analysis\, a
 nd risk management. Participants will gain the skills to design robust stab
 ility programs that comply with global guidelines (ICH\, FDA\, EMA) while o
 ptimizing product shelf life and quality.  \nThis training aligns with in
 dustry needs by ensuring compliance\, reducing regulatory risks\, and impro
 ving product stability strategies.\nLearning Objectives\nBy the end of this
  training\, participants will be able to:  \n\nApply ICH guidelines (Q1A\
 , Q5C) to design stability studies for biopharmaceuticals.  \nDevelop a s
 tability study protocol with appropriate storage conditions\, sampling poin
 ts\, and test methods.  \nAnalyze stability data using statistical tools 
 to predict shelf life and degradation trends.  \nMitigate risks in stabil
 ity programs by identifying critical variables and failure modes.  \nImpl
 ement strategies for handling deviations and out-of-specification (OOS) res
 ults.  \nPresent stability data effectively for regulatory submissions. 
  \n\nKey Topics \nModule 1: Introduction to Stability Studies in Biopharm
 a - Importance\, objectives\, and industry challenges.  \nModule 2: Regul
 atory Guidelines (ICH\, FDA\, EMA) - Key requirements for stability testin
 g in biologics.  \nModule 3: Stability Study Design & Protocol Developmen
 t - Selection of batches\, storage conditions\, and test intervals.  \nM
 odule 4: Case Study: Stability Protocol Review - Hands-on evaluation of a 
 real-world protocol.  \nModule 5: Stability Data Evaluation & Statistical
  Tools - Trend analysis\, shelf-life estimation (ANOVA\, regression).  \
 nModule 6: Handling OOS & Deviations in Stability Studies - Root cause anal
 ysis and corrective actions.  \nModule 7: Risk-Based Stability Program Op
 timization - Identifying critical parameters and failure modes.  \nModul
 e 8: Regulatory Submissions & Mock Audit Exercise - Preparing stability re
 ports for inspections.  \nAssessment & Interaction \n\nQuizzes after key
  modules.  \nGroup exercises (protocol drafting\, data analysis).\nFeedbac
 k forms for continuous improvement.\n\nTarget Audience\n\nRoles: Stability 
 scientists\, QA/QC professionals\, regulatory affairs specialists\, formula
 tion scientists.  \nPrerequisites: Basic knowledge of GMP\, stability test
 ing principles\, and biopharmaceutical product development.\n\nKey Takeaway
 s \n\nMaster stability study design aligned with ICH guidelines.  \nAppl
 y statistical methods for shelf-life prediction.  \nDevelop risk-based st
 ability strategies for compliance.  \nEnhance regulatory submission readi
 ness.  \nResolve stability-related deviations effectively.  \n\nSpeaker\
 nKossi Molley\, Chimiste\, LSSBB\, PMP
LOCATION:Online
DTSTAMP:20260726T005050Z
DTSTART:20260826T130000Z
DTEND:20260827T200000Z
END:VEVENT
END:VCALENDAR