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Training
Join our new different model and experience of learning by doing training programs.
We translate what is written in books to practical work and real experience
We offer our trainees performing practical work on different pharmaceutical quality control instrumental devices to gain our experts knowledge and their experience in the troubleshooting in different cases
Our courses
Quality control and HPLC Fundamentals: Code#101
Who is this course for?
This course is suitable for all levels of knowledge; from beginners up to those with limited experience, or as a refresher for the more experienced chemist or pharmacist.
What you'll learn
This course introduces the fundamentally important concepts of GLP, HPLC analysis including hardware basics, modes of analysis, column chemistry, and principles of separation techniques along with the hands-on practical element in the laboratory to practice and re-enforce the theoretical knowledge. You will also learn basic fundamentals of Spectroscopy with focus on UV Spectroscopy theories and applications. These course is 50% theory and 50% practical in a lab environment.
Course Content
GLP
> What is GLP?
> History of GLP.
> GLP scope
> The fundamental points of GLP
Pharmaceutical compendial testing
> What are the compendial testing?
> USP general tests
Chromatography and HPLC fundamentals
> Introduction to chromatography
> Liquid chromatography theory
> HPLC chromatographoic terminology
Case studies:
Hands-on 3 different HPLC analysis cases for each trainee starting from the sample preparation till raw data calculation and reporting.
Spectroscopy :
> What is Spectroscopy?
> Basic theories of Spectroscopy
> Spectrometers’ components
> Spectroscopy terminology
> Spectrophotometers types
Case studies: Hands-on 3 different UV analysis cases for each trainee starting from the sample preparation till the end results.
Advanced HPLC training: Code#102
Who is this course for?
This course is suitable for Analytical chemistry postgrad students, junior quality control analysts in pharmaceutical industry, analytical postgraduate study or for those or for who have an experience in HPLC and want to re-enforce their knowledge and gain extra-experience
What you'll learn
This course is designed to provide a deep explanation of logical HPLC method development, the course discusses the crucial aspects of method development with relevant examples to give a deeper understanding.
We build our troubleshooting approach based on both the component and the chromatogram perspectives.
By learning the fundamentals of method validation you will be able to evaluate whether the precision and accuracy obtained for the procedures are appropriate for its intended use or not.
Course Content
HPLC method development :
> Sample preparation
> System choices
> Choosing column and mobile phase
> Optimization strategies
> Quantitation & system characterization
HPLC troubleshooting:
> Overview on logical troubleshooting
> Component perspective
> Symptomatic perspective
HPLC Method validation
> Fundamentals of method validation
> Method validation procedures
Quality Assurance : Insights and Application of Basic Concepts: Code َ#QA101
Who is this course for?
This course is designed for beginners who are interested in learning about quality assurance concepts, and to those who want to enrich their theoretical knowledge through ways of implementing them in practice.
What you'll learn
The course primarily lays a foundation on the basics of pharmaceutical quality assurance. Practical training is then provided through technical application, which includes the development of documents such as standard operating procedures and forms. You will also learn how to apply key concepts in QA compliance: handling deviations with appropriate root cause analysis during investigation, and how to manage change control and audits.
Course Content
This module provides training in the field of quality assurance, with emphasis placed on :
Pharmaceutical Quality Assurance
> What is Quality Assurance?
> The role of QA in pharmaceutical industries
> Introduction to GMP and Compliance
Documentation
> General Principles
> Types of Documents
> How to Write an SOP
Good Documentation Practice
> What is GDP?
> How to apply GDP?
Training of Personnel
> Types of Training
> Planning for Training
> How Training is Implemented
> Training Evaluation
> Recording of Training
Change Control
> Definition
> Change Classification
> How to perform a Change Control ?
Non-Conformities
> Definition
> Classification of Non-conformities
> Handling of Non-conformities
> Root Cause & Impact Analysis
> CAPA
Management of Audits
> Definitions
> Types of audits
> Audit process
Fundamentals of EU Regulatory Affairs Course code #RA101
Who is this course for?
Graduate student from different scientific backgrounds such as pharmacy, science, chemical engineers, etc.
For personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products
What you'll learn
This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe, you will gain a clear understanding of the EU regulatory structure, the submission process and the standards required through a practical insight into the European regulatory environment concerning the whole product life cycle including: non-clinical and clinical studies, the various submission procedures, labelling and packaging, post-MAA obligations and activities and more.
Course Content
- An overview of the EMA and the various types of MAAs.
- The regulatory affairs throughout the product development including R&D, manufacturing, clinical trials and PV.
- An insight into the new CT Regulation and to prepare for future changes.
- The CTD with a detailed focus on the CMC/quality module, non-clinical study reports module and clinical study reports module.
- The requirements of packaging and labelling pharmaceutical products in the EU.
- How to file for variations in your product post approval for efficient life cycle management?
Essentials of Egyptian Pharmaceutical Regulatory Affairs Course code# RA102
Prerequisite : Nothing
Who is this course for?
Graduate student from different scientific backgrounds such as pharmacy, science, agriculture &medicine (human or veterinary).
Employee working in pharmaceutical field seeking to know more about regulatory affairs specialty
Investors who are interesting in pharmaceutical industry
What you'll learn
The rule of regulatory affairs specialist in pharmaceutical industry
Overview of the major requirements to license a pharmaceutical company
Overview of registration life cycle of pharmaceutical products in EDA (The Egyptian Drug Authority)
Course Content
> Overview of the rule of regulatory affairs specialist in pharmaceutical industry
> Overview of the major requirements to license a pharmaceutical company
> Different strategies of selecting the suitable product to start your business
> Milestones of registration life cycle of pharmaceutical products in EDA
> Major differences between the current effective ministerial decrees of registration of pharmaceutical products
Registration life cycle of pharmaceutical products in EDA Course code# RA103
Prerequisite : RA102
Who is this course for?
Graduate student from different scientific backgrounds such as pharmacy, science, agriculture &medicine (human or veterinary)
Regulatory Affairs specialists of less than 1-year experience
Employee working in pharmaceutical field seeking to know more about regulatory affairs specialty
What you'll learn
Registration life cycle, in details, of pharmaceutical products in EDA (From inquiry request to license)
Course Content
Overview of registration steps of ministerial decrees no. 296 & 425
Hands-on training to explain how to :
- Prepare and submit inquiry request*
- Prepare and submit naming request*
- Prepare and submit pricing request according to ministerial decree no. 499
* According to ministerial decree no. 425
Hands-on training to explain how to :
- Prepare and submit pilot batch appointment
- Prepare and submit NODCAR file (i.e. registration file)
Hands-on training to explain how to :
- Prepare and submit stability file (i.e. 6 months accelerated study)
- Submit vivo & vitro studies
Hands-on training to explain how to :
- Prepare and submit leaflets to pharmacology department
- Prepare and submit layout to naming & layout department
- Prepare and submit registration file according to ministerial decree no. 425
- Understand registration license contents & requirements
Different types of variation requests
Hands-on training to explain how to :
- Prepare and submit different variation requests to the registration license such as :
> Supplier addition requests
> Composition change requests
> Site addition or site transfer requests
> Ownership transfer requests
- Extensions requests and re-registration requirements
Project Management Professional (PMP) Certification preparation: Code#MA101
Who is this course for?
This course is designed for project managers, team leaders which are targeting leadership positions, Key team members, functional managers, process and performance improvement team members, business planning personnel or those who would like to enhance their career through Project Management Certification.
What you'll learn
This course will enhance your skills, help you grow in your career as well as expand your marketability, you will be able to validate your dedication to your job and to manage projects in structured and reputable fashion.
It is an efficient way to learn the core concepts of project management, it will help candidates to develop and improve the necessary skills for a career in the executive management.
Course Content
- What is PMP?
- Why PMP?
- PMI&PMP
- Benefits of PMP certification
- PMBOK
- Project attributes
- What is project management?
- Project life cycle and phases
- Roles and competencies of PM
ISO 9001:2015 : Code#MA102
Who is this course for?
This course is designed for individuals either who are interested to gain the knowledge about the Quality Management System (QMS) or those are responsible for maintaining conformance with QMS requirements, auditors seeking to perform and lead Quality Management System Certification audits, managers or consultants seeking to master a Quality Management System audit process, technical experts seeking to prepare for a Quality Management System audit or expert advisors in Quality Management.
What you'll learn
At the end of the course will be able to understand the purpose and business benefits of Quality Management System (QMS), Quality Management System standards, management system audits and third party certification, you will also identify the benefits of an ISO9001:2015 QMS as well as understanding the key terms, definitions and the requirements of the standards and to grasp the significance of organizational context, leadership and adopting a risk based approach.
Course Content
- ISO 9001 History
- Benefits of quality management system
- Key terms and definitions
- High level structure
- Quality Management Principles
- Introduction to ISO 9001:2015
- ISO 9001:2015(Clause 4-10)
- Conversion process and timeline