Pharmaceutical and biotech companies modify validated systems only through change control, with documented testing and evidence an inspector can review. Replacing an algorithm, a cryptographic library, or a certificate authority in a GxP system counts as one of those changes. Signed records also have to stay trustworthy for their whole retention period. An EU clinical trial master file has to be retained for at least 25 years after the trial ends. Regulators and industry bodies set the cryptography for submission gateways and trading-partner credentials, so part of your plan depends on their timelines.

We run this intensive as a full-day, hands-on workshop. You bring your own GxP system inventory, validation procedures, and supplier list. You leave with a migration plan ready for quality review.

Who this intensive is for

IT quality and computerized system validation leads, manufacturing and laboratory systems owners, serialization and supply chain leads, regulatory operations, and CISOs and security architects who will own the plan.

Send a mixed group from one company. The person who owns the validation master plan rarely owns the TLS configuration or the trading-partner credentials.

Bring at least one person from quality assurance. Many of the sequencing decisions in this workshop are change control decisions.

If you run a health system or build medical devices, the Quantum-Safe Healthcare Intensive covers your estate.

What you’ll be able to do afterward

• Build a cryptographic inventory from your list of GxP systems and their validation records, and mark what you control against what a vendor, regulator, or trading partner controls
• Classify a cryptographic change by GxP risk, choose the testing and evidence your change control procedure requires, and explain the choice to an inspector
• Design validated systems so you can change an algorithm once, in qualified infrastructure, and regression-test the applications that depend on it
• Plan how signed records stay verifiable through retention periods of 25 years or more, without breaking audit trails or ALCOA+ expectations
• Map the cryptography you depend on and cannot change yourself, from FDA and EMA submission gateways to DSCSA trading-partner credentials and serialization data standards
• Write post-quantum and crypto-agility clauses into supplier contracts and quality agreements with contract development and manufacturing organizations (CDMOs), and add matching entries to user requirements specifications

What you leave with

Every participant receives the course handbook, a PDF of the full material with the instructor notes written out. Each participant also receives a PDF copy of Quantum Ready. During the day you start a cryptographic inventory from your list of GxP systems and build a classification matrix for cryptographic changes. You also draft a signature longevity plan for one regulated archive, a register of dependencies on regulators, trading partners, and suppliers, and clauses for contracts and quality agreements. All are editable and yours to keep.

The day

Morning, first block. The validated estate. Working from your own GxP system inventory, find the cryptography in validated applications, manufacturing systems, and laboratory instruments. Mark what you control, what a vendor controls, and what a regulator or trading partner sets.

Morning, second block. Change control. How change control, supplier assessment, and periodic review apply to replacing an algorithm, a cryptographic library, or a certificate authority. You classify a hybrid TLS rollout on a validated manufacturing execution system and decide what test evidence it requires.

Afternoon, first block. Records and partners. Keeping signed records verifiable across decades of retention without altering the originals. Then the gateways, trading-partner credentials, and serialization standards you cannot migrate on your own schedule.

Afternoon, second block. The plan. Assemble the roadmap against the EU, NIST, and UK NCSC milestones. Draft the supplier and CDMO language, and identify the decisions that need quality assurance, a vendor, or a trading partner.

Where this course fits

We recommend Quantum-Safe Healthcare before this day. It covers pharma, health systems, and medical devices at overview depth. Participants who have taken it already know the terms we use during the day. Afterward, architects should take Cryptographic Agility: Design and Implementation. The people who find the cryptography in your systems should take Cryptographic Discovery, Inventory, and CBOM. Whoever leads supplier and CDMO conversations after this workshop should take PQC Vendor Governance and Supply Chain.

Why we teach this

This intensive is built on the Applied Quantum PQC Migration Framework, published openly under Creative Commons at pqcframework.org. Our instructors teach the manufacturing and laboratory sessions from its OT/CNI Extension. No published extension covers GxP validation yet, so the instructors teach it from their own field work.

Certificate of Completion

Upon completion, you receive a Quantum Academy certificate of completion. It confirms that you completed the course and is separate from Quantum Academy’s professional certifications.

Enrollment includes 180 days of access to the corresponding online on-demand course. Where that course is not yet published, the 180 days start on the day it is.

About this program

Quantum Academy credentials are private professional credentials issued by Quantum Academy, a trade name of Post-Quantum Institute. They are not government-issued licenses, accredited degrees, or academic credit, and earning one does not guarantee employment, promotion, regulatory approval, or any other specific outcome.

Quantum Academy programs are educational and informational only, and are not legal, compliance, or engineering advice.