PharmaTraining Services Integrated Tablet Formulation Development, API Development
Cost effective and timely pharmaceutical development depends on high standards of core technical skills. Our mission is to offer specialist, in-depth training by experts, in key areas which are not comprehensively covered at present.
- Integrated Tablet Formulation Development
- Tablet Process Development
- GMP Auditor Training
- How to Audit API Manufacturers
- API Development, Supply and Commercial Manufacture
- Stability Testing
- Physical Properties
- Poorly Soluble Drugs
- Amorphous Materials
Typically our speakers have been involved in pharmaceutical teaching and training for over 20 years.
Attendance for each course is limited to give participants quality time with our speakers.
Integrated Tablet Formulation Development, Process Development and Validation
The object of tablet development is to develop a quality product which is reproducible, with a reliable process, has the required appearance and properties and which is economical and easy to manufacture.
The Integrated Tablet Formulation Development course will explain the key techniques of preformulation, excipient compatibility, tablet components and their function, how to approach tablet formulation and development, small scale manufacturing processes and also the manufacture and stability testing of final formulations.
Process Development and Validation will explain what “Process Development” is and why it is done and will also cover “design space”, selecting the final manufacturing conditions, how to build a validation protocol and validation report.
GMP Auditor Training
Reasons for audits and audit models – what will you do?
Tools and techniques – how will you do it?
The audit process – completing the audit and follow up?
Improving the audit system – appraisal and improvement of the existing system.
GMP auditor training covers the key techniques and insights to help plan, prepare and structure a successful GMP audit. By educating both auditors and auditees in these techniques auditing will help achieve business and compliance improvements. Participants learn about the leglislators’ perspectives and the key differences between APIs and products which lead to different audit techniques.
Pharmacokinetics in Drug Development
What is PK and why is it important?
- Absorption, distribution, metabolism and elimination
- Drug failures
- Therapeutic windows
The course on pharmacokinetics in drug development will give an explanation of pharmacokinetic terms, factors contributing to variability, how emerging data and the regulatory environment influence PK strategy. The course also covers bioavailability, first in man studies, the place of PKPD modelling and simulation in drug development.
Active Pharmaceutical Ingredient (API) Development
The active pharmaceutical ingredient (API) is a key element of the drug development process.
This course will provide an overview of the development of chemical processes for the supply of Active Pharmaceutical Ingredients, from the selection of a new candidate, discovery into development through to the commercial launch.
This course would be of benefit to chemical and process engineers, chemical analysts, formulation scientists and health, safety and environment professionals, technology transfer and manufacturing.
How to Audit API Manufacturers
The purchase of starting materials is an important operation which should involve staff who have a particular and thorough knowledge of the suppliers.
This course covers the requirements of Directive 2004/27/EC, how the regulators audit and enforce the requirements, what role the secondary manufacturer’s play, what the similarities are with the FDA GMP requirements for APIs and what the expectations are from the API manufacturers.
Stability Testing in Pharmaceutical Development
Stability testing is a universally important activity common to all product types and phases of pharmaceutical development and manufacture requiring an extensive knowledge of a wide range of techniques of product and material characterisation.
This course will provide participants with a full understanding of pharmaceutical stability testing, including: Why it is required; clinical trial requirements and global industry standards.
Formulation Strategies for Poorly Soluble Drug Substances
Understanding the challenges of your Active Pharmaceutical Ingredient and how that will impact on the formulation selection.
Describing the basic theory and how to develop a strategy for dealing with poorly soluble drug substances, including salts and physical form changes, amorphous solid dispersion systems, lipid based formulations, solubilisation approaches and self emulsifying systems.
For any enquires about PTS and its programme of courses - contact our manager Judy Callanan at any time.