GMP, records and the event
Assess a fictional manufacturing event. Review records, define the problem and decide immediate containment.
Output: Event timeline and deviation draft.
OPTIMAL ACADEMY
GMP training for
confident daily practice.
From a two-hour introduction to a five-day applied workshop. Practical learning for pharmaceuticals, biopharmaceuticals and advanced therapy manufacturing.
ELEVEN COURSES · FLEXIBLE PATHWAYS
Choose your learning pathway
Courses can stand alone or form a role-based programme.
Select a course to explore the content.
G01GMP essentials2 hours
Who: New starters, contractors and staff needing a refresher.
Topics: Patient and product protection, roles, hygiene, contamination, material flow, records and escalation.
Practice: Knowledge check and a personal action list.
Enquire about G01 ↗G02Good documentation and data integrity3 hours
Who: Operators, QA/QC, engineering and document owners.
Topics: Clear entries, corrections, attributable records, contemporaneous recording, audit trails and ALCOA+ concepts.
Practice: Review a sample batch or laboratory record.
Enquire about G02 ↗G03Deviation writing, RCA and CAPA1 day
Who: Quality, production, maintenance and engineering teams.
Topics: Problem statement, immediate actions, evidence collection, causal analysis, impact assessment and CAPA effectiveness.
Practice: Draft a deviation, root-cause rationale and CAPA plan.
Enquire about G03 ↗G04OOS / OOT investigations2 days
Who: Teams with relevant GMP or technical experience.
Topics: Initial laboratory assessment, manufacturing investigation, hypothesis testing, retest/resample rationale, impact and reporting.
Practice: An evidence-based investigation plan and conclusion.
Enquire about G04 ↗G05Qualification and validation2 days
Who: Teams with relevant GMP or technical experience.
Topics: Lifecycle planning, risk and system impact, requirements, DQ/IQ/OQ/PQ, process validation and change control.
Practice: A validation outline with traceability.
Enquire about G05 ↗G06Cleaning validation1 day
Who: Teams with relevant GMP or technical experience.
Topics: Product grouping, worst case, limits, sampling, recovery and hold times.
Practice: A cleaning-validation strategy exercise.
Enquire about G06 ↗G07Contamination control and aseptic readiness2 days
Who: Teams with an agreed product and process context.
Topics: Contamination pathways, facility/utilities, personnel, monitoring and aseptic interventions.
Practice: A case-based contamination-control action plan.
Enquire about G07 ↗G08Audit and inspection readiness1 day
Who: Department leads, quality staff and process owners.
Topics: Evidence retrieval, interview practice, observation response, ownership and action closure.
Practice: Conduct a mock interview and prepare a response plan.
Enquire about G08 ↗G09Technology transfer and analytical lifecycle2 days
Who: Teams with relevant GMP or technical experience.
Topics: Knowledge transfer, receiving-site gaps, process/equipment equivalence, method transfer and lifecycle monitoring.
Practice: A transfer risk and evidence map.
Enquire about G09 ↗G10GMP for biopharma and advanced therapies2 days
Who: Teams with an agreed product and process context.
Topics: Tailored product/process risks, contamination control, starting materials, traceability and complex manufacturing interfaces.
Practice: A product-specific risk workshop.
Enquire about G10 ↗G11Applied GMP quality workshop5 days
Who: Teams requiring a connected, applied GMP programme.
Topics: A connected case covering records, investigation, root cause, CAPA, validation and technical writing.
Practice: A connected investigation and validation evidence pack.
Enquire about G11 ↗A full day is 6 facilitated learning hours, excluding breaks. The five-day workshop provides 30 facilitated hours. Detailed scope, prerequisites and assessment are agreed before booking.
Prerequisites
Relevant GMP or technical experience is recommended for technical courses. G01 is recommended for newcomers. Specialist courses require an agreed product and process context.
G11 · 30 FACILITATED HOURS
Five-day applied GMP workshop
A connected case, from event to justified action.
OOS / OOT and investigation logic
Examine laboratory and manufacturing evidence. Plan hypothesis tests and consider the basis for retesting or resampling.
Output: Investigation plan and evidence log.
Root cause, CAPA and risk
Test causal explanations, assess wider impact and develop proportionate corrective and preventive actions.
Output: Root-cause rationale, risk assessment and CAPA plan.
Validation and change control
Map requirements to evidence. Review qualification, process and cleaning-validation interfaces within the case.
Output: Validation outline and change-control impact review.
Technical writing and challenge
Complete the report, present conclusions and respond to a mock quality-review panel. Agree workplace application.
Output: Reviewed evidence pack and a 30-day action plan.
A learning simulation using fictional or client-approved, de-identified information.
DELIVERY, ASSESSMENT & BOOKING
A training plan shaped around your team.
Experienced facilitators
Consultants with over 50 years’ combined GMP experience across pharma, biopharma and advanced therapy manufacturing. Facilitator experience is matched to the agreed course scope.
Flexible delivery
Live online, on-site or blended. We recommend 8–16 participants for practical workshops so each team receives feedback. Larger awareness sessions can be arranged. Confirm facilitator availability and dates when booking.
Evidence of learning
Knowledge checks, practical exercises and facilitator feedback. Longer programmes can include agreed assessment and workplace follow-up. Optimal Academy issues attendance certificates or completion certificates following the agreed assessment. This catalogue carries no NQF credits or CPD points.
Your proposal
Course scope and learning outcomes, duration, facilitator profile, participant numbers, delivery method, materials and assessment. Travel, venue requirements and additional coaching are specified separately.
Pricing on request
Share your topic, team size, location and preferred dates.
Reference frameworks include applicable EU GMP guidance and FDA OOS guidance. Course content is tailored to your requirements and controlled procedures.