Course Description
In today’s highly regulated pharmaceutical environment, a well-designed stability program is not just a regulatory requirement—it is critical to ensuring product quality, patient safety, and successful market approval. Yet, many organizations continue to struggle with ineffective study design, inadequate data interpretation, and costly regulatory observations.
This practical, expert-led training provides a complete, real-world understanding of how to design, implement, and defend an FDA-compliant stability program across the product lifecycle
Agenda
Day 1: Stability Foundations & Regulatory Expectations
👉 Understand what regulators expect — and why stability failures happen
What You’ll Learn
- Why stability programs are critical for product quality & patient safety
- Key terminology simplified:
- Shelf life vs expiration vs re-test date
- Stability-indicating methods & in-use period
- Types of stability studies:
- Long-term, accelerated, stress testing (and when to use each)
Regulatory Insights (2026 Focus)
- FDA, EMA, ICH (Q1 series), WHO expectations
- Differences: small molecules vs biologics
- Real-world regulatory trends & common inspection findings
Handling Deviations
- Managing OOS (Out-of-Specification) results
- Investigation approach & documentation expectations
Day 2: Designing a Robust Stability Program
👉 Learn how to build stability programs that pass inspections
Clinical & Development Strategies
- Stability approaches across clinical phases (Phase I–III)
- API vs Drug Product (DP) stability differences
- FDA vs EMA expectations during development
System & Infrastructure Readiness
- Stability sample tracking systems (data integrity focus)
- Qualification & monitoring of stability chambers
- Calibration & compliance requirements
Protocol Design Made Practical
- Selecting:
- Batches, storage conditions, testing intervals
- Stress conditions & in-use studies
- Bracketing & matrixing explained simply
- Applying Quality by Design (QbD) to stability
Methods & Testing
- Choosing stability-indicating methods
- Key differences for biologics vs chemical drugs
Day 3: Shelf Life, Submissions & Inspection Readiness
👉 Turn your stability data into approvals and audit success
Shelf Life Determination (Simplified)
- Essential statistics for stability (no heavy math)
- Trend analysis & regression basics
- Arrhenius approach explained practically
- Defining “significant change”
Regulatory Submissions (CTD/eCTD)
- Presenting stability data in:
- Module 2.3 (QOS)
- Module 3 (Quality)
- Minimum data expectations
- Post-approval stability commitments
Lifecycle & Post-Approval
- Managing ongoing stability programs
- Handling product changes (ICH Q12 concepts)
- “Stability budget” & distribution considerations
Inspection Readiness
- What FDA/EMA inspectors look for
- Common deficiencies from Warning Letters
- Avoiding data integrity & fabrication risks
Who Should Attend
- QA/QC, Stability & Analytical teams
- Regulatory Affairs professionals
- R&D and Formulation scientists
- Manufacturing & Quality professionals
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
