Training Catalog

This training offers extensive content synthesized from current dietary supplement directives, regulations, and legal mandates.

We offer a comprehensive training program covering the definition and composition of dietary supplements, regulatory-compliant ingredient control, and the identification of quality control tests. The content also includes establishing specification limits and the certification verification of raw materials used in supplement manufacturing.

We provide theoretical and practical training sessions based on ICH, EMA, and FDA guidelines, covering topics such as wet chemistry, instrumental analysis, chromatographic systems, method selection, sample preparation, and concentration determination.

Our training provides in-depth answers to key questions: What are the foundations of validation and verification according to latest guidelines and pharmacopeias? How should they be applied based on the analytical method and technique used? And what are the core documentation requirements?

We provide comprehensive content that explores the fundamentals of method transfer in alignment with current guidelines and pharmacopeias. The training addresses how to execute transfers based on specific methods and analysis types, while detailing the essential documentation principles.

We offer detailed content, referenced by current guidelines, covering the identification, monitoring, limit calculation, and reporting of organic and inorganic impurities, residual solvents, and elemental impurities in both Active Pharmaceutical Ingredients (APIs) and finished drug products.

We offer training content developed in compliance with current guidelines.

We offer detailed content, referenced by ICH, FDA, and EMA guidelines, that explores the definition of specifications, the various types of specifications, and how they should be tailored for different pharmaceutical dosage forms.

We offer a comprehensive training program on the implementation of stability studies for Active Pharmaceutical Ingredients (APIs) and finished drug products in compliance with current guidelines. The content covers the fundamentals, study designs, execution, and reporting of photostability and in-use stability studies.

In accordance with current guidelines, we provide detailed insights into the content and practical application of pharmacopoeias.

We offer a comprehensive training program, referenced by current guidelines, that explores the definition of a Drug Master File (DMF), its required CTD sections, and the critical focus areas during the DMF review process.

We offer a comprehensive training program providing a strategic overview and assessment of nitrosamines, referenced by ICH, FDA, and EMA guidelines. The content covers critical details such as their definition, significance, limit setting, and monitoring strategies.

In compliance with FDA and EMA guidelines, we offer a comprehensive training program detailing characterization studies for diverse pharmaceutical dosage forms, including solids, semi-solids, liquids, inhalations, and nasals. The content specifically explores comparative characterization strategies between reference and generic drug products.

In accordance with current guidelines, we offer a comprehensive training program on forced degradation studies. The content covers the definition and objectives of degradation testing, methodologies, parameter explanations, study design, evaluation of results, calculation of mass balance, and documentation requirements.

In compliance with pharmacopoeial standards, we offer a comprehensive training program for solid dosage forms covering sink and solubility definitions, the Biopharmaceutics Classification System (BCS), study design, calculations, and reporting requirements.

In compliance with pharmacopoeial standards, we offer specialized training on the preparation of CTD Sections 3.2.P.5.5 (Characterization of Impurities) and 3.2.P.5.6 (Justification of Specifications) for drug product registration dossiers.

In compliance with FDA and EMA guidelines, we offer a comprehensive training program on establishing therapeutic equivalence between reference and generic drug products. The content details in-vitro study designs, required testing protocols for diverse dosage forms (solids, semi-solids, liquids, inhalations, nasals, etc.), and the calculation and assessment of similarity results.

We offer a comprehensive training program on the selection, implementation, and evaluation of statistical calculations tailored to specific analytical methods and study contexts.

In compliance with pharmacopoeial standards, we offer a detailed training program on uniformity analysis for various pharmaceutical dosage forms. The content covers the implementation and evaluation of content uniformity, uniformity of tube content, delivered dose uniformity, and weight uniformity of the administered dose.

We offer a comprehensive training program on Good Manufacturing Practices (GMP), developed in full compliance with ICH, FDA, and EMA guidelines.

We offer comprehensive training materials aligned with the latest global standards and guidelines.

We offer comprehensive training materials aligned with the latest global standards and guidelines.

We offer comprehensive training materials aligned with the latest global standards and guidelines.

We offer comprehensive training materials aligned with the latest global standards and guidelines.

We offer comprehensive training materials aligned with the latest global standards and guidelines.

We offer a comprehensive training program covering the fundamentals of liquid chromatography and its applications. The content focuses on analytical method development for HPLC and UPLC systems, including detector selection and other essential technical parameters.

We offer a comprehensive training program on columns used in HPLC, UPLC, and GC systems. The content covers column selection criteria, efficient column utilization, and essential maintenance strategies for chromatographic excellence.