PharmaTraining courses

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

...Auditing of an API site (II) SOPs and SOP training Calibration Testing laboratories Packaging and labelling Storage and distribution Summary of Key Issues...

...to define a logical procedure Write a concise, unambiguous SOP for its intended purpose Ensure the document is written for the correct audience Link...

...Compile your own checklist for Phase 1 and Phase 2 OOS investigations. Adjust your quality systems and SOPs to ensure OOS investigations are more effective...

...the design or implementation of tablet process validation protocols. Tablet formulation and process development staff and those involved in managing process...

...this course Effervescent products present particular problems in manufacture, which result from their special requirements and particular utility...

...It will include: A comprehensive review of ICH guidance Pitfalls in stability testing Outsourcing—costs and benefits New approaches to stability testing...

...Overview The course is highly interactive and held in a relaxed environment. It will cover: Why do we do photostability tests? Concepts and background...

...All levels of staff who are involved in documentation as a daily activity in the pharmaceutical and related industries in the following areas...

...Session 2 15.30 to 17.30pm Phase 1 Case studies These are interactive group exercises where the participants utilise their experience and new learning’s...

..."Quality by Design" and definition of the product Design Space. Data from each phase is used to control the next step in the development process...

...is there importance PK techniques Non compartmental Analysis Compartmental modelling Population pharmacokinetics Regulatory environment Data interpretation Day...

...with international regulatory guidelines. Overview Analytical methods must be validated to provide reliable data for regulatory submissions...

...Fulfill an effective role in developing Technical, Quality, Supply and Service Level Agreements. Influence issues that appeared to be outside control...