Why study at TECH?

The Postgraduate diploma in Processing and Development of Sterile Pharmaceutical Products contains the most complete, unprecedented and up to date scientific program on the market"

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Industrialized medicine has been a breakthrough in current therapeutics, since many patients have found a remedy for their illnesses.

However, this industrialized drug does not cover all therapeutic needs. For various reasons, there are therapeutic gaps that only the Individualized Medicine can fill.

The Master Formulation or, nowadays, "individualized medicine" is the essence of the pharmaceutical profession. It has been the starting point of human medicine therapeutics, when patient care was individualized.

The master formula, understood as the medicine intended for an individualized patient, prepared by or under the direction of a pharmacist, to expressly comply with a detailed medical prescription of the medicinal substances it includes, requires that the professional activity be adjusted to strict and faithfully reproducible procedural guidelines. In this sense, pharmacists need to be updated and promote continuous training in the knowledge and compliance with the standards for the correct preparation and quality control of master formulas in order to achieve the required level of quality.

The objective of this program is to train pharmacists in a discipline unique and exclusive to their profession, training professionals who can respond to therapeutic gaps with the formulation of an individualized drug with the quality and efficacy of an industrialized drug.

The Postgraduate diploma in Processing and Development of Sterile Pharmaceutical Products contains the most complete and up to date scientific program on the market"

This Postgraduate diploma in Processing and Development of Sterile Pharmaceutical Products contains the most complete and up to date scientific program on the market. The most important features of the program include:

  • Clinical cases presented by experts in the different specialties. The graphic, schematic, and eminently practical contents of which they are composed provide scientific and practical information on the disciplines that are essential for professional practice
  • Sterile Pharmaceuticals Processing and Development News
  • Algorithm-based interactive learning system for decision-making in the presented clinical situations
  • With a special emphasis on evidence-based medicine and research methodologies in Processing and Development of Sterile Pharmaceutical Productsv
  • All this will be complemented by theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection assignments
  • Content that is accessible from any fixed or portable device with an Internet connectionv
  • Disponibilidad de los contenidos desde cualquier dispositivo fijo o portátil con conexión a internet
  • Availability of content from any fixed or portable device with an Internet connection

This Postgraduate diploma may be the best investment you can make in the selection of a refresher program for two reasons: in addition to updating your knowledge in the Processing and Development of Sterile Pharmaceutical Products, you will obtain a Postgraduate diploma from TECH Global University"

Its teaching staff includes health professionals belonging to the field of pharmacology, who bring to this training the experience of their work, in addition to recognized specialists belonging to leading scientific societies.v

The multimedia content developed with the latest educational technology will provide the professional with situated and contextual learning, i.e., a simulated environment that will provide an immersive training program to train in real situations.

This program is designed around Problem Based Learning, whereby the physician must try to solve the different professional practice situations that arise during the course. This will be done with the help of an innovative interactive video system developed by renowned experts in the field of pharmacology with extensive teaching experience.v

Increase your confidence in decision making by updating your knowledge through this Postgraduate diploma in Processing and Development of Sterile Pharmaceutical Products"

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Don't miss the opportunity to update your knowledge in Processing and Development of Sterile Pharmaceutical Products to improve patient care"

Syllabus

The structure of the contents has been designed by a team of professionals knowledgeable about the implications of training in daily pharmaceutical practice, aware of the relevance of current training in order to develop individualized dosage forms in a safe and efficient manner and committed to quality teaching through new educational technologies.

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This refresher program will generate a sense of security in the elaboration of dosage forms, which will help you grow personally and professionally"

Module 1. Application of the Quality Assurance and Control System for Master Formulas and Office Preparations. R.D.175/2001

1.1. Standards of Correct Elaboration and Quality Control

1.1.1. Quality Management Systems
1.1.2. Personal

   1.1.2.1. Responsibilities
   1.1.2.2. Training
   1.1.2.3. Hygiene

1.1.3. Premises and Tools

   1.1.3.1. General Characteristics of the Premises
   1.1.3.2. General Equipment Characteristics

         1.1.3.2.1. General Equipment
         1.1.3.2.2. Specific Equipment

1.1.4. Documentation

   1.1.4.1. General Documentation
   1.1.4.2. Documentation related to Raw Materials
   1.1.4.3. Packaging Material Documentation
   1.1.4.4. Documentation related to Master Formulas and Official Preparations

1.1.5. Raw Materials and Packaging Material

   1.1.5.1. Origin

        1.1.5.1.1. Raw Materials Acquired from an Authorized Center
        1.1.5.1.2. Raw Materials Acquired from Other Entities
        1.1.5.1.3. Raw Materials Centralized by the Administration
        1.1.5.1.4. Packaging Material

                 1.1.5.1.4.1. Glass
                 1.1.5.1.4.2. Plastic

                             1.1.5.1.4.2.1. PVC
                             1.1.5.1.4.2.2. PET
                             1.1.5.1.4.2.3. PP
                             1.1.5.1.4.2.4. PE

  1.1.5.2. Reception and Quarantine
  1.1.5.3. Conformity Control
  1.1.5.4. Documentation

1.1.6. Production

  1.1.6.1. Production by Third Parties

1.1.7. Dispensing and Labeling

   1.1.7.1. Patient Information
   1.1.7.2. Labelling

1.2. General Procedures

1.2.1. Introduction
1.2.2. Objectives
1.2.3. General Procedures

  1.2.3.1. PG for Internal Documentation Management
  1.2.3.2. GP for the Development of Procedures
  1.2.3.3. GP for Managing Records
  1.2.3.4. PG for Cleaning and Disinfection Premises and Equipment
  1.2.3.5. GP for Personnel Hygiene and Clothing
  1.2.3.6. GP of Subcontracting
  1.2.3.7. GP of Shopping
  1.2.3.8. GP for Product Storage, Conservation and Disposal
  1.2.3.9. GP for Team Management
  1.2.3.10. GP for Toration and Qualification
  1.2.3.11. GP for the Study, Elaboration and Dispensing of Master Formulas and Office Preparations
  1.2.3.12. GP for the Labeling and Dispensing of Master Formulas and Office Preparations

1.3. Development of Standard Operating Procedures

1.3.1. Weighing Work SOPs
1.3.2. Powder Mixing and Production SOPs
1.3.3. Disaggregation SOPs
1.3.4. SOPs for the Manufacture of Hard Gelatin Capsules
1.3.5. SOP for the Production of Gastroresistant Capsules
1.3.6. SOPs for Gel Production
1.3.7. SOPs for Solutions Production
1.3.8. SOPs for Ointment and Paste Production
1.3.9. SOPs for Emulsions Production
1.3.10. SOPs for Suspensions Production
1.3.11. SOPs for the Production of Paper Rolls
1.3.12. SOPs for Sterile Preparations

Module 2. Biopharmaceutics and Pharmacokinetics

2.1. New Aspects of Galenic Pharmacy

2.1.1. Introduction
2.1.2. Chemical, Therapeutic and Biological Equivalence of Medicines
2.1.3. Biopharmaceutics and Basic Pharmacokinetics
2.1.4. Pharmaceutic Technology
2.1.5. Clinical Pharmacokinetics

2.2. Evolution of Medicines in the Body

2.2.1. LADME
2.2.2. Kinetics of LADME Processes
2.2.3. Release as a Limiting Factor for Absorption

2.3. Absorption Mechanisms

2.3.1. Passive Diffusion
2.3.2. Convective Diffusion
2.3.3. Active Transport
2.3.4. Facilitated Transport
2.3.5. Ion Pairs
2.3.6. Pinocytosis

2.4. Routes of Administration

2.4.1. Oral Route

   2.4.1.1. Physiological Factors Affecting Gastrointestinal Absorption
   2.4.1.2. Physicochemical Factors that Limit Absorption

2.4.2. Topical Route

    2.4.2.1. Structure of the Skin
    2.4.2.2. Factors Influencing the Absorption of Substances Through the Skin
    2.4.2.3. Parenteral Route

          2.4.2.3.1. Parenteral Aqueous Solutions
          2.4.2.3.2. Delayed Parenteral Solutions

Módulo 3. Formas farmacéuticas estériles

3.1. Definition of Sterile in Master Formulation
3.2. Expiration Dates of Sterile Dosage Forms

3.2.1. Protocols for Producing Sterile Products

  3.2.1.1. Work GP
  3.2.1.2. Microbiological Control SOPs
  3.2.1.3. Lyophilization Protocol

3.3. Sterilization

3.3.1. Heat Sterilization

  3.3.1.1.  Humid Heat
  3.3.1.2. Dry Heat

        3.3.1.2.1. Sterilization of Oils
        3.3.1.2.2. Sterilization of Glass Materials
        3.3.1.2.3. Tindalization

3.3.2. Sterilization by Filtration

  3.3.2.1. Types of Filtration

3.3.3. Other Types of Sterilization
3.3.4. Disinfectants

  3.3.4.1. Most Frequent Disinfectants

3.4. External Sterile Pharmaceutical Forms. Eye Drops and Ointments
3.5. Internal Sterile Pharmaceutical Forms: Parenterals and Freeze-Dried

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A unique, key, and decisive training experience to boost your professional development”

Postgraduate Diploma in Processing and Development of Sterile Pharmaceutical Forms

The development of sterile dosage forms is a key process in the pharmaceutical industry, since it is essential to guarantee the safety and quality of the drugs produced. With the Postgraduate Diploma in Processing and Development of Sterile Pharmaceutical Forms, the student will be able to acquire the necessary skills to work in this area of pharmaceuticals.This program offers updated training in the techniques and technologies used in the processing and development of sterile pharmaceutical forms, both injectable and non-injectable. The student will learn about sterilization processes, equipment and materials needed, different types of containers and their sterilization, as well as container filling and sealing techniques.In addition, this Postgraduate Diploma also focuses on quality management and compliance with health standards and regulations that affect the development and manufacture of sterile dosage forms. The student will acquire knowledge on GMP and ISO 14644 regulations, among others, as well as on risk management and process validation.

Deepen your knowledge of pharmaceutical research

The preparation offered in this program is highly specialized and is aimed at professionals in the pharmaceutical sector who wish to broaden and update their knowledge in the elaboration and development of sterile dosage forms. Theoretical contents are combined with practice and real cases, which allows students to learn first-hand about the processes and procedures used in this field. In short, the Postgraduate Diploma in Processing and Development of Sterile Pharmaceutical Forms is a unique opportunity to specialize in a highly specialized and constantly evolving field, and to acquire the necessary skills to work in the pharmaceutical industry with the maximum guarantees of quality and safety.