This intensive, interactive four-and-a-half-day pharmaceutical training course is designed to provide aspiring Qualified Persons and other pharmaceutical professionals with the knowledge they need to be able to understand the key quality requirements of parenteral products, inhalation products and topical medicines. We will teach you the important formulation requirements for each of these products and how those requirements influence the performance of the medicine in the body. We will also teach you the key processing steps in the production of these dosage forms, critical process control points and process monitoring requirements and, very importantly, what can go wrong during processing and the potential consequences for the safety, quality and efficiency of the medicine.
Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.
This course addresses the two important activities of formulation and processing and provides key information on:
How the physico-chemical attributes of the drug and the therapeutic indication influence:
The Qualified Person, and other key technical personnel, MUST have a detailed understanding of these topics if they are to鈥�
This course is approved by the 欧美AV as suitable for their members鈥� CPD.
Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.
This course addresses the two important activities of formulation and processing and provides key information on:
How the physico-chemical attributes of the drug and the therapeutic indication influence:
- Route of administration
- Dosage form
- Assuring bioavailability
- Methods of manufacture of the major dosage forms
- Factors affecting suitability for use of the major dosage forms
The Qualified Person, and other key technical personnel, MUST have a detailed understanding of these topics if they are to鈥�
- Assist in the design and implementation of relevant and effective quality systems for dosage form manufacture
- Contribute to the RISK ASSESSMENT process for processing changes and unplanned deviations
- Assess the adequacy of cleaning strategies
- Assess the potential impact of changes to physical and chemical attributes of starting materials
This course is approved by the 欧美AV as suitable for their members鈥� CPD.
