PharmaTraining courses

...audits * Auditors of suppliers and contractors Overview This 2 day course is aimed at Quality Assurance auditors and production management for Level...

...secondary products should play on enforcing these requirements What is the impact on manufacturers? How to apply the requirements to non EU API sites...

...Understand the purpose and benefit of effective SOPs Understand the critical role of SOPs in Quality Documentation systems Use various tools such as flowcharting...

...The workshop emphasizes practical issues such as: The importance of good quality support systems FDA audit observations and how they could have been avoided...

...Use of Process Matrices in process development. Unit processes 1—Mixing and blending Assessing blend uniformity. Sampling problems and practice Workshop...

...Why do they present problems? Course Programme Try it! The workshop... Using a laboratory tablet machine and some simple equipment, we experiment...

...The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing. Suitable for: People working...

...Formulating and manufacturing unstable products Formulation development and evaluation for photolabile materials Protection during the manufacturing process...

...systems for document management in the pharmaceutical development and manufacturing areas. Course Outline: Questions and answers will be taken throughout...

...The course material is based on the FDA guideline “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”, October 2006 Course...

...Course Programme (4 days) Day 1 morning: Preformulation Preformulation studies in context Key techniques in preformulation Excipient and process compatibility...

...PK in Drug Development Pre-clinical/clinical interface What PK data are available, how does this influence the Clinical PK strategy? Biomarkers Implications for...

...Group discussion Day Two Developing stability-indicating methods Requirements for a stability-indicating analytical method Anticipation of likely degradation...

...Challenge other functions to prioritise quality and regulatory systems accordingly. Overview Rapidly changing regulatory frameworks, business models...