training for pharmaceutical teams.
Programmes built around the work your team actually does — inspection findings, batch records, deviation investigations, transfer protocols. Delivered on site or remotely, and scheduled around your operation rather than a fixed public calendar.
Durations below are indicative and are tailored to your team size and starting point. Tell us what you need and we will come back with a proposed outline and dates.
what we teach.
gmp & schedule m readiness
What Schedule M expects of a site in practice, and how inspection findings actually arise.
- For
- Production and QA staff, site leadership
- Length
- 2 days (indicative)
- Format
- On-site or virtual
Covered
- Schedule M structure and what it requires of premises, equipment and personnel
- Documentation practice — batch records, logbooks and data integrity basics
- Common inspection observations and their root causes
- Self-inspection: running an internal audit that finds real problems
regulatory documentation & submissions
Building submission-grade documentation, and why applications come back with queries.
- For
- Regulatory affairs and QA teams
- Length
- 2 days (indicative)
- Format
- On-site or virtual
Covered
- Licence classes and which pathway applies to which product
- Technical document structure and common deficiencies
- Labelling requirements by regulatory schedule
- Managing queries and post-approval changes
quality systems: deviations, oos & capa
Running deviation and CAPA processes that close root causes rather than paperwork.
- For
- QA and QC personnel, production supervisors
- Length
- 1–2 days (indicative)
- Format
- On-site or virtual
Covered
- Classifying deviations and setting investigation depth
- Root cause analysis techniques that hold up under review
- Designing corrective and preventive actions that are verifiable
- Effectiveness checks and trending
technology transfer & process validation
Moving a product between sites or scales without losing control of the process.
- For
- Production, QA and technical services teams
- Length
- 2 days (indicative)
- Format
- On-site or virtual
Covered
- Transfer planning, risk assessment and documentation
- Critical process parameters and quality attributes
- Validation strategy and protocol design
- Handling scale-up deviations and re-validation triggers
pharma business fundamentals for brand owners
The commercial and regulatory groundwork a new pharmaceutical brand needs before its first order.
- For
- Founders and commercial teams new to pharmaceutical manufacturing
- Length
- 1 day (indicative)
- Format
- Virtual or on-site
Covered
- How third-party manufacturing works and what you remain responsible for
- Licensing, GST and documentation obligations for a brand owner
- Reading a manufacturer compliance position before you commit
- MOQ, costing and packaging decisions that shape unit economics
request a programme.
Tell us which programme interests you, roughly how many people, and where you are starting from. We will propose an outline, a duration and possible dates.
Need something not listed? Describe it — most programmes started as a specific request.