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PIC/S GMP Compliance & Inspection Readiness for Pharmaceutical Professionals Course & Certification
Intermediate
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3 hours
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PIC/S GMP Compliance & Inspection Readiness for Pharmaceutical Professionals
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About
The PIC/S GMP Compliance & Inspection Readiness course is designed to provide a comprehensive understanding of Good Manufacturing Practice (GMP) requirements under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) framework and the principles necessary to maintain continuous inspection readiness. It emphasizes the importance of quality systems, regulatory compliance, data integrity, risk management, and operational excellence in ensuring the consistent manufacture of safe, effective, and high-quality pharmaceutical products.
This course covers key areas including PIC/S GMP Guide (PE 009) requirements, Pharmaceutical Quality Systems (PQS), quality risk management, documentation and record control, data integrity and ALCOA+ principles, deviation management, CAPA systems, change control, supplier qualification, self-inspections, audit preparation, inspection management, GMP culture, quality oversight, validation and qualification concepts, complaint handling, outsourcing controls, and regulatory expectations. It also highlights inspection-readiness strategies, root-cause analysis, continuous improvement practices, and practical approaches for successfully managing regulatory inspections and maintaining ongoing GMP compliance. Upon completion, learners gain the knowledge and skills required to support inspection-ready operations and strengthen quality systems within pharmaceutical and regulated manufacturing environments.
Who Should Enrol?
- Quality Assurance (QA) Professionals
- Quality Control (QC) Analysts and Supervisors
- GMP Compliance and Quality Systems Personnel
- Manufacturing and Production Staff
- Validation and Qualification Specialists
- Regulatory Affairs Professionals
- Internal Auditors and Lead Auditors
- Supplier Quality and Vendor Management Personnel
- Laboratory and Analytical Personnel
- Pharmaceutical, Biotechnology, and Medical Device Professionals
- Managers and Supervisors Responsible for GMP Compliance
- Anyone involved in inspection readiness, quality improvement, and regulatory compliance activities
What you will learn
Understand the fundamentals of PIC/S GMP Compliance & Inspection Readiness, including PIC/S GMP requirements, regulatory expectations, Pharmaceutical Quality Systems (PQS), and the principles of maintaining continuous compliance and inspection readiness.
Gain knowledge of GMP documentation practices, data integrity and ALCOA+ principles, quality risk management, deviation handling, CAPA systems, change control processes, supplier qualification, and self-inspection programs.
Learn how to apply GMP requirements across manufacturing, quality control, quality assurance, validation, and outsourced activities while ensuring effective oversight of processes, products, and data.
Develop understanding of inspection preparation strategies, audit management, root-cause analysis, inspection conduct, regulatory communication, and corrective action implementation.
Course Syllabus
- Context - why PIC/S GMP and inspection readiness matter
- Audience - who this course is for
- Outcomes - what you will be able to do
- Roadmap - the nine modules
- What PIC/S is and why harmonisation exists
- The PE 009 GMP Guide - Part I, Part II and annexes
- GMP and patient safety - quality equals safety
- Compliance culture versus a checklist mentality
- Putting it into practice
- Personnel, training, competency and hygiene
- Premises and contamination control
- Equipment qualification, calibration and maintenance
- Materials management, traceability and segregation
- Good documentation practice
- Batch records
- Pharmaceutical Quality System fundamentals (ICH Q10)
- Roles, responsibilities and the Authorised Person
- Deviations, investigations and root cause analysis
- CAPA, change control and effectiveness checks
- Complaints, recalls, management review and PQR
- ICH Q9 overview and risk-based thinking
- The risk management lifecycle
- Risk assessment tools - FMEA, HACCP and ranking
- FMEA basics - severity, occurrence, detection and RPN
- Risk-based decisions and residual risk
- Applying QRM
- Why data integrity matters
- ALCOA+ principles explained
- Paper, electronic and hybrid records
- Audit trails, access control and Annex 11
- The data lifecycle
- Common data integrity failures
- Inspection types and how regulators inspect
- Preparation and readiness
- Behaviour during an inspection
- Handling findings and observations
- After the inspection
- Chapter 7 - contract giver and acceptor responsibilities
- Supplier and vendor qualification
- Technical and quality agreements
- Monitoring supplier performance
- Supply chain integrity and falsified medicines
- Risk & decisions
- GMP principles in compounding and aseptic preparation
- Risk-based approach to preparation
- Aseptic practices and media fills
- Environmental monitoring and trending
- Documentation, labelling and release
- Staff, training and culture
- What a quality culture is and why it matters
- Leadership and tone from the top
- Speaking up and just culture
- Continuous improvement
- Measuring & sustaining culture
- Your role and a 30-day action plan
- Course complete
- 📘 Bonus: PIC/S GMP Compliance & Inspection Readiness eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with changes to the PIC/S GMP Guide (PE 009 and its annexes, including the revised Annex 1 and Annex 11), ICH Q9 and Q10, and evolving regulatory expectations on data integrity and inspection readiness, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by GMP and quality-assurance practitioners with regulatory inspection experience, so that learners can apply PIC/S expectations confidently in manufacturing, quality and hospital-pharmacy environments.
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