Many pharmaceutical companies tend to characterize their GMP practices as recording the rules and production steps that the personnel must follow during production. However, GMP is a comprehensive set of rules where not only the production of Pharmaceutical Products, but also the steps to be followed in all processes including R&D activities during the product life cycle are validated and recorded. GMP disasters in history have caused tragedies in many companies that cannot be erased. Many countries allow the import and sale of pharmaceutical products produced according to the current GMP rules, which are internationally recognized. GMP (Good Manufacturing Practices), a concept settled in the terminology as Good Manufacturing Practices, usually appears as cGMP (current Good Manufacturing Practices) supported by the FDA. The letter c added to the beginning of the GMP means “up-to-date” and actually refers to the constantly updated and living rules outside of the “apply and produce what is” logic of GMP. With Advanced GMP training, all sections updated in FDA, EU, PIC/S, MHRA, WHO GMP Guidelines, all innovations in Concept Papers, Draft Articles and Latest Innovations in International GMP Guidelines will also be covered. With this wide-ranging training, you will learn both to refresh your existing knowledge, to access new information and to learn the subjects that you could not find the opportunity to learn in superficial GMP trainings. After the lectures, your GMP knowledge will be at the highest level with Scenario Studies. In addition to the training presentation, BONUS documents will also be presented.
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Certified GMP Advanced Master Class – ONLINE/ LIVE
As the name suggests, GMP Advanced Master Class has very detailed topics.
At the end of the training, the participants will;
- Learn about international GMP guidelines and regulations
- Understand what the health authority’s GMP expectations are
- Learn all GMP rules that Sterile and Non-Sterile production facilities must comply with
- Be amazed by the negative and traces of the GMP disasters throughout history.
- Realize how GMP-compliant facilities need to apply other quality management standards
- Have detailed information on Quality Risk Management, Change Management, Deviation Management, CAPA Management, Technology Transfer, Annual Product Review, Validation, Qualification, Out-of-Limit& Trend Management, Storage and Shipping Requirements, Personnel Requirements, Good Documentation Practices, Site Master File, Pharmacopoeia, Sampling Principles, Release Methods, Sterilization, Hygiene and Sanitation Rules, Stability and many other topics.
This training package will be presented in 3 Days. Each day will cover several topics. Whole training will end within 3 days.
Day 1 ( 26 July, 2021)
- Introduction to GMP and its History
- GMP Disasters
- GMP & Quality Management
- GMP & ISO Integration
- GMP & Personnel
- GMP & Facilities & Equipment
- GMP & Documentation
- GMP & Production
- GMP & Quality Control
- GMP & Outsourcing
- GMP & Complaints and Recalls
- GMP & Internal Audits
- GMP & API & Excipient
- GMP & Annexes
- Scenario Study
Day 2 ( 27 July,2021)
- International GMP Guidelines
- EU, FDA, PIC / S, TGA, Canada, WHO, ICH GMP
- Validation & Qualification & Calibration
- Supplier Qualification
- Validation Types and Master Plans Preparation
- Validation Protocols & Reports
- Qualification (URS, FAT, SAT, DQ, IQ, OQ, PQ)
- GMP & Sterile Productions
- Documentation & Records & SOP
- GMP & Risk Based Audits
- GMP & Material Receiving & Packaging / Labeling
- OOS & OOT & Deviations & Root Cause & CAPA
- Change Control
- Sampling Techniques
- Storage and Temperature & Humidity Controls & Mapping
- Scenario Study
Day 3 ( 28 July,2021)
- GMP & In-Process Controls
- Responsibilities of Senior Management
- Training & Performance & KPI
- Use of Pharmacopoeia
- Hygiene & Sanitation & Gowning and Code of Conduct
- Annual Product Review
- GMP & Laboratories
- Chemicals, Reagents, Solutions
- Business Continuity
- Technology transfer
- Stability
- Scenario Study
Mustafa Edik
After graduation as a Chemist from University, Mustafa Edik began his more than 23 years of career as a Laboratory Supervisor in German Pharmaceutical Company named Bayer. 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 to Turkish Atomic Energy Authority as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim in all health authorities and Industry. He has prepared and presented various trainings, workshops to more than 7.000 individuals from 100 International and Local Pharmaceutical, Medical Device and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He took part in several International Pharmaceutical Facility Establishment projects as GMP Consultant. He set up various Quality Management Systems to Local Pharmaceutical and Medical Device Companies. While he was the Vice President of Quality and Technical Operations at Quality Academia Training & Consultancy firm, he acquired and convert it to a 100 % Turkish Company. As an only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey he currently conducts API, Excipient, Packaging Materials Suppliers & Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, WHO regulations and guidelines. He finished his second university degree at Biopharmaceutical Sciences BSc (Hons) in 2019.
WHICH STAFF?
• GMP Compliance
• Quality Assurance & Quality Control
• Validation & Stability
• R&D
• Auditing
• Regulatory Affairs
• IT
• Warehouse & Supply Chain
• Engineering
• Procurement
In order to participate in the training, REGISTRATION must be completed. An e-mail is sent to the participant after registration.
Tuition fees; Certificate, Training documents and Bonus are included. Certificates are delivered electronically to the participants by the Trainer / Trainers at the end of evaluation of the training. Payments (including VAT) must be made to the bank account declared in advance within the specified dates. Payment receipts should be sent to info@qualityacademia.com Registration is done in order of payment. QA reserves the right to delete the participant’s registration without notice for payments that are not made without a written justification until 15 days prior to the training date. In written cancellation notifications made 15 days before the training date, 20% of the tuition fee is refunded. No refunds are made for later cancellations, only name changes are made. The invoice to be issued is sent by courier to the address and to the notified person after the training. The completed registration is a commitment. It is the responsibility of the invoiced person or company if the participant is not present in the training hall (face to face or online trainings), which was notified on the date of training. Training announcements are made 30-90 days before training. Quality Academia reserves the right to make changes to the training date, training hall and instructor without prior notice.
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Early Registration (Until 31 May 2021) |
Pre-Event Registration (Between June 1, 2021 – June 30 2021) |
Registration During the Event (July 26,2021 ) |
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1.200 USD / 1-3 Person 1.100 USD / 4-7 Person 1.000 USD / 8-12 Person |
1.300 USD / 1-3 Person 1.200 USD / 4-7 Person 1.100 USD / 8-12 Person |
1.400 USD / 1-3 Person 1.300 USD / 4-7 Person 1.200 USD / 8-12 Person |
University / Government Institution / Student Discount
Those who want to benefit from the discount must first specify the University, Institution, Student e-mail address during registration.
In order to be eligible for a discount, the dates in the table above should be taken into account. The discount rate is 15% for 1 Person. The increase in the number of participants will not cause any increase in the discount.
Online training is one of the most effective learning methods and it is very important for the continuous training of Pharmaceutical, Biotechnology, Medical Device industries staff. Quality Academia Training & Consultancy offers online opportunities completely specific to its client company’s needs and expectations. On-line trainings consist of modules that client staff will access by logging in with their user name and password, and adjust the time and speed according to the working conditions. Each module is user friendly. Some of the QA’s pre-recorded online modules are as follows; Good Manufacturing Practices, Good Laboratory Practices, Good Distribution and Storage Practices. QA also runs online live webinars on several GXP related topics such as GMP (Good Manufacturing Practices), GDP (Good Distribution practices), GQCLP (Good Quality Control Laboratory Practices), GSP (Good Storage Practices) etc.
Please get in touch with us if you have online corporate training needs at info@qualityacademia.com
Ceritificate Validity
The certificate issued at the end of the training will be valid for 3 years from the date of issue. At the end of the third year, retraining may not be taken, but it is necessary to take the relevant evaluation exam.
Exemplar Global Inc. provides personnel certification, credential management for individuals seeking further professional recognition and independent certification for training providers to enhance their course quality and outcomes. We build career pathways that support your career pathway. Our 25 years of building certification programs for our customers has provided us with the expertise to partner with you in the design, development, and delivery of a sustainable, recognized career for your profession. Our goal is to help guide your career requirements through our knowledge of what industry is seeking. At Exemplar Global, we believe that the right people with the right skills deliver the right outcomes.
