Quality Control function is critical in a GMP-compliant facility. There are special sections and rules regarding Quality Control activities in the EU, PIC / S, MHRA, FDA, TMMD, WHO GMP guidelines and regulations. The roles and responsibilities of quality control in the Pharmaceutical and Biotechnology industries are clearly defined in approved procedures. Quality Control department should be independent of the production department and should have methods, procedures, materials, equipment, areas and personnel that can perform all tests of both raw materials and finished products. Job descriptions of staff should be available and all pharmacopoeia tests performed should be verified or validated. Quality Control department should be aware of its responsibilities to the legal authority and always be ready for the necessary inspections.
- Bu etkinlik geçti.
Certified Quality Control Manager- ONLINE/ LIVE
Those who successfully complete the Quality Control Manager training will be in a very advantageous position.
Participants will
- Have information about the duties and responsibilities of the Quality Control Manager
- Understand the qualifications of a GMP-compliant quality control laboratory
- Have an idea about how the Quality Control laboratory will be located
- Witness how the workflow will take place in a GMP Compliant Quality Control Lab
- Clarify the details of the plans and reports of the maintenance, calibration and qualification of equipment and devices.
- Understand the tips of Analytical and Microbiological Method Validation
- Become a quality control manager candidate that the Pharmaceutical and Biotechnology Industries are looking for and will gain numerous advantages over their competitors in job applications.
This training package will be presented in 60 hours. Each week will cover 20 hours. Whole training will end within 3 weeks in 60 hours totally.
1st Week (14-15-16 June 2023)
- GMP Compliance in the Laboratory
- GMP Compliant Quality Control Manager Roles and Responsibilities
- Good Quality Control Laboratory Practices
- How to Design a Quality Control Laboratory?
- How to Provide Workflow in the Laboratory?
- Preparation of Laboratory SOPs
- Equipment Calibration and Maintenance
- Basic Analytical Techniques
- Analytical Method Transfer
- Analytical Method Development and Validation
- Stability Indicating Method Development
- System Suitability Tests
- HPLC Method Development
- Analyst Selection & Evaluation & Qualification
- Laboratory Document Management System
- Analytical Standards Management
- Management of Reagents and Solutions
2nd Week (21-22-23 June 2023)
- Use of Pharmacopoeia
- Sampling Process Management
- Out of Limit / Out of Trend Management in the Laboratory
- Raw Material / Finished Product Analysis
- Sample Reduction & Test Reduction
- Statistical Methods in Quality Control
- Laboratory Safety
- Laboratory Inspection Preparations
- Stability Tests
- Specifications
- Impurities
- Calculations
- Elemental Impurities
- Electronic Signature and Electronic Records Management
- Data Integrity Management in the Laboratory
- Microbiology Laboratory Design
- Media
3rd Week (28-29-30 June 2023)
- Sterilization and Sterility Assurance
- Sterility Test
- Bacterial Endotoxin Test
- Biological Indicators
- Lean Laboratory Applications
- Rapid Microbiological Tests and Validations
- Validation, Qualification
- Developing a Contamination Control Strategy
- Environmental Monitoring Systems
- Automatic Identification Systems
- Aseptic Technique
- Gowning Behaviors According to GMP
- Disinfectant Qualification
- Aseptic Process Simulation
- Microbial Tests in Water, Steam, Gas Systems
- Microbial Risks in Non-Sterile Production Facilities
Manager’s Talent Toolbox (4 topics each week) - Communication Techniques for Effective Leadership
- The Art of Asking Smart Questions
- Management of Different Characters and Differences of Ideas
- Golden Rules for Igniting Success
- Creative Problem Solving and Decision Making
- Interdepartmental Cooperation
- Peaking Performance
- GMP Compliant Perfect Team Building Secrets
- Talent Hunting and Value Adding Stars
- 25 Features of the Manager
- 100 Ways to Inspire Your Staff
Mustafa Edik
He graduated from ATU with a BSc (Hons) in Biopharmaceutical Sciences. Mustafa Edik began his more than 25 years of career as a Laboratory Supervisor in a 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 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, and 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 for 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.
WHICH STAFF?
• GMP Compliance
• Quality Control
• Validation & Stability
• R&D
• Regulatory Affairs
• Warehouse & Supply Chain
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 28 April 2023) |
Pre-Event Registration (Between May 1, 2021 – June 9 2023) |
Registration During the Event (June 14,2023 ) |
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4.500 USD / 1-3 Person 4.250 USD / 4-7 Person 4.000 USD / 8-12 Person |
4.600 USD / 1-3 Person 4.350 USD / 4-7 Person 4.100 USD / 8-12 Person |
4.700 USD / 1-3 Person 4.450 USD / 4-7 Person 4.200 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.
