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Two-Day Live Training
AI in Pharma
Manufacturing & Quality
Practical tools, regulatory guardrails, and high-value use cases for quality, manufacturing, and operations teams in pharma and biotech.
Dates
December 2–3, 2026
Time, both days
8:00 AM to 12:00 PM ET
Format
Live, online · 8 hours
The Agenda
What You’ll Learn
Two half-day live sessions with hands-on exercises and time for your questions.
Day 1 · December 2
Foundations, Quality, and Manufacturing
- Why AI now: generative AI and large language models in plain language
- Hands-on with ChatGPT and Claude: prompting that works
- Governance, regulation, and ethics: FDA and EMA principles, draft EU GMP Annex 22, and data security
- Quality use cases: deviations, change control, visual inspection, and document drafting
- Manufacturing operations: predictive maintenance, continued process verification, batch release, and supply chain
Day 2 · December 3
Implementation and Governance
- Advanced applications: formulation, drug discovery, and robotics
- Implementing AI: leadership, three ways to get started, and a practical roadmap
- An AI governance process for GxP: FDA and EU guidance, risk tiers, and a checklist
- Validating AI applications: a risk-based approach and ongoing monitoring
- Data quality for AI: why AI is only as good as the data behind it
- Tips, pitfalls, and open Q&A
Who Should Attend
Quality, manufacturing, operations, validation, and regulatory professionals in pharma and biotech. No technical background needed.
Taught By
Your Presenters
Amie Harpe
Owner & Principal Consultant, Sakara Digital
23 years at Pfizer in Quality Operations and Digital Solutions. Amie now leads AI readiness and roadmap work for pharma and biotech companies.
Kevin Jenkins
Principal Consultant, Quality Operations, Sakara Digital
More than 40 years in pharmaceutical quality and operations, including 36 years at Pfizer in VP-level roles in Aseptic Quality and Established Products Quality Operations.
Before You Register
Good to Know
Payment
Credit or debit card, processed securely by Stripe. Your receipt is emailed as soon as payment completes.
Registering a team
Choose the number of seats in one checkout. We will follow up to collect each attendee’s name and email.
Joining details
Your live session link and course materials arrive by email by Monday, November 30.
Certificate
Attendees who join both sessions receive a certificate of completion.
Cancellations
Full refund if you cancel by November 18, 2026. After that, you can send a colleague in your place or move your seat to a future workshop. Read the registration terms.
Questions
Email info@sakaradigital.com.