Presented by
Management Forum
Thinking Beyond Traditional GMP (Good Manufacturing Practice) In-house Training
In this two-day course, you'll gain a whole new perspective on GMP requirements, including how to implement them.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
This training course has been specifically designed to help you step back and look at GMP differently - not as a set of regulations to follow, but as a framework that can be evaluated from multiple perspectives to strengthen processes and enhance performance.
As the pharmaceutical industry continues to evolve in response to technological advancements, increasingly rigorous regulatory expectations, updated and expanding guidelines, and the needs of the end-user patient, the importance of effective GMP implementation has never been greater. Simply complying is no longer enough; organisations must ensure their systems are robust, efficient, and future-focused.
During this course, core GMP topics are explored from a fresh and practical perspective. You will refresh your existing knowledge while gaining new insights and expertise that support stronger application in the workplace. The course encourages broader thinking around GMP implementation, helping you better understand how to interpret, apply and optimise regulatory requirements within your organisation.
To reinforce learning, the sessions include scenario-based discussions and practical examples. In addition, delegates receive complementary bonus documents alongside the training materials to support implementation of newly learned techniques back at work.
By the end of the course, you will have enhanced your GMP knowledge and gained practical tools to apply regulatory requirements more effectively, confidently, and strategically.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.
Benefits of attending
- View GMP requirements from multiple practical and strategic perspectives
- Apply regulatory expectations more effectively within your own organisation
- Strengthen GMP systems using risk-based and modern thinking approaches
- Identify opportunities to optimise processes while maintaining compliance
- Enhance quality culture through improved interpretation and application
- Translate regulatory requirements into practical workplace solutions
Who should attend
This course is particularly beneficial for:
- QA and QC professionals
- Production and Manufacturing Managers
- Regulatory Affairs personnel
- Qualified Persons and Responsible Persons
- Validation and Technical Services staff
- Anyone responsible for implementing, maintaining or improving GMP systems
- Professionals seeking a broader, more strategic perspective on GMP application
This course will cover:
Introduction to GMP regulations
- What is GMP?
- International guidelines and directives for GMP
Management responsibility
- Who are 'Top Management'? Can we reach them?
- What are the main responsibilities of 'Top Management'?
- How does 'Top Management' approach and manage risks?
- Do they ask smart questions on the shop floor?
Lessons learnt from other industries
- GMP excellence by design
- Aviation and Automotive industries best practices
- The 'learning by doing' approach in a regulated environment
Learning organisation and quality culture
- What is 'knowledge management'?
- Do we learn effectively what’s taught?
- Is it different than that of quality risk management?
- Quality culture in Pharma and Biotech industries
- Which one is the best? Company culture or quality culture?
Personnel and training expectations in GMP
- How to simplify trainings without compromising GMP rules
- How to select and qualify personnel
- Aligning job descriptions with cGMP
- How to deal with passengers in a QC laboratory
- New employee orientation program structure
- Proven tactics of keeping the GMP training records
- What are the ten training errors?
Documentation pitfalls
- How to simplify documentation without compromising GMP rules
- Real dangers behind data integrity applications
- How to handle data for GMP expectations
- How to reduce or eliminate documentation errors
- How do you ensure data integrity during validation?
Group exercise: let’s improve our SOPs in microbiology laboratory
Deviation management and CAPAs
- How to simply handle deviations by asking lateral questions
- Who is responsible for the deviation or OOS?
- Sophisticated PAs approaches
- Where’s CA gone?
- Why is it so exhaustive to find the true root cause?
GMP behaviour models
- How to change old GMP behaviours
- Why multitasking is lurking somewhere in GMP compliance
- Four magic words for GMP Compliance
- Eliminating the non-value-added activities form GMP
A new validation approach
- How to handle deviations in cleaning and process validation
- Is it possible to reduce the costs in validation activities?
- How to prevent sampling errors in validation
- How to simplify computerised system documentation? (computer software assurance and GAMP5 – second edition)
- Successful QC integration with GMP compliance
Knowledge-based change control
- What is 'knowledge-based change control'?
- Change control vs. change management
- How to adapt QRM to changes
- How to avoid pitfalls in CC
- How frequently to monitor the effectiveness of changes
- FDA 483s for change control
Before and after shutdown
- Things to do before and after facility shutdown
- Do we have to repeat aseptic process simulation?
- What are the main responsibilities of the engineering department during the shutdown period?
- How to switch from preventive maintenance to predictive maintenance
- How robust are our critical utilities (HVAC, water, steam, gas) according to current GMP guidelines?
Complaints and recalls
- What is risk-based recall management?
- Who manages complaints in your company?
Group exercise: audit shortcuts
Technology transfer best practices
- How to manage aseptic product technology transfer?
- What are the main pillars of GMP compliant test method transfer?
- How to prevent drug shortages without compromising GMP expectations?
Outsourcing
- How to find the most appropriate quality agreement template
- Effective tactics to manage quality when outsourcing
- What lessons to learn from Heparin and other crises
Do you know your GMP compliance score?
- Is it possible to achieve 100% GMP compliance?
- How to implement a gap analysis to detect quality problems
- Do you know how to measure your GMP performance?
- How elegant is your GMP system?
- How to spot weakness in GMP compliance?
Mustafa Edik
Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.
His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.
Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:
- GMP/GDP audits and supplier qualification
- Validation, qualification, and quality risk management (ICH Q9)
- Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
- Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
- Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
- Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards
Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.
A prolific author, Mustafa's works include:
- “Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
- “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices
Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.
Denmark
- Ferrosan Medical Devices
- Ferrosan Medical Devices A/S
Algeria
- Novonordisk
Switzerland
- Janssen
United Kingdom
- University of Sheffield
Run Thinking Beyond Traditional GMP Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
