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Some of our Training Programs
QbD Quality by Design
A practical approach for drug product lifecycle.
Concepts and Principles includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.
Concepts and Principles includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.
QRM Quality Risk Management
QRM principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.
Data Integrity
Data is an important asset, data integrity is highly important for industrial sectors, however, it is more important than others when we speak about pharma, where any data error could mean serious consequences.
CSV Computer System Validation
This course will provide you with an overview of what matters in validation of computerized systems (including CSA) to help your company meet regulatory requirements and mitigate risks to product quality and patient safety.
Validation, Qualification and Calibration
The program is designed to provide not only a detailed description of the major requirements for validation master system and different aspect of validation and qualification, but also a practical methodology on how to establish, update, control, review and audit the validation system at all sides
GMP Good Manufacturing Practice
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
EDA regulations Under-Scope
- EDA regulations course has been designed to guide you with the essential knowledge, latest updates and best practices in Egyptians regulations concerning; Pharmaceutical products, dietary supplements, cosmetics and herbal products registration.
RA Profession & CTD
Regulatory function in health care has a great importance in ensuring Quality, safety and efficacy of healthcare products
From the regulatory function importance, we understand the need of internationally agreed format to assemble all quality, safety and efficacy information in common format called Common Technical Document (CTD).
Our interactive workshop will cover all basics of CTD preparation.
From the regulatory function importance, we understand the need of internationally agreed format to assemble all quality, safety and efficacy information in common format called Common Technical Document (CTD).
Our interactive workshop will cover all basics of CTD preparation.
(CMC)
Chemistry, Manufacturing and Controls
CMC is the term used to describe all the aspects of making pharmaceutical products
The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier.
API Master Files is an essential part of module 3 of CTD .
During our journey, we will discover all API Master File sections together with related guidelines,
CMC linkage between API & drug product and how to best assess contents in light of regulatory requirements.
The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier.
API Master Files is an essential part of module 3 of CTD .
During our journey, we will discover all API Master File sections together with related guidelines,
CMC linkage between API & drug product and how to best assess contents in light of regulatory requirements.
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