When you look at the bigger picture, it is possible to see that Good Manufacturing Practice (GMP), which we have difficulty in implementing from time to time, can actually be evaluated from different perspectives which can provide insight that gains even more value for your GMP processes and application This training course has been specially prepared to serve exactly this purpose.
In the rush to fully meet technological developments in the pharmaceutical industry, together with the expectations of the health authorities; updated and evolving guidelines; and the needs of the end-user patient, the emphasis on complying with the GMP regulations and guidelines is becoming increasingly important. In this GMP training course, the topics will be examined with a very different perspective, enabling you to refresh your existing knowledge and gain new expertise on the subject. After the sessions, your GMP knowledge will be enhanced with scenario studies and bonus complementary documents which will be given in addition to the training programme and will aid your application of the new learnt techniques to the work place.
Benefits of attending
- Gain an insight into top management's approach to risks
- Learn the training and documentation system, including planning GMP trainings and process mapping tips
- Understand the personnel selection criteria in accordance with GMP
- Explore GMP compliant lateral-thinking techniques, behaviour change models in GMP and the mechanisms to prevent errors in sampling and validation
- Ensure cost reduction tactics in validations
- Adapt lessons learnt from other sectors to GMP
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
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
Day 2
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?
Speakers
Mustafa Edik,
Independent GMP Consultant and AuditorAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
Who Should Attend
Personnel who are in a wide range of GMP-related jobs will benefit from this course, including those in:
- Quality Assurance
- Quality Control
- GMP Compliance
- Validation
- Engineering
- Operation
- Manufacturing
- Supply Chain
- Logistics
- IT
- Purchasing
