PharmaTraining courses

...Purpose of the self inspection programme Establishing the programme Setting up and training the inspection team Conducting the inspection and reporting...

...and EU interpretation of GMPs for APIs specific opportunities from the guidelines that API manufacturers may exploit specifics of what to look for when auditing an API...

...Day 1 8.30 Registration and Coffee Morning Session 1 - 9.00 to 10.30am • Introduction • Individual Exercise • Benefits of SOPs • Global Harmonisation of...

...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...

...published in 2009, will be comprehensively reviewed. Course Outline Day 1: Morning—Product development The new regulatory landscape. Q8, Q9 and Q10 and...

...Uniformity – achieving and assessing uniformity in effervescent systems. Taste and taste masking ODTs Specific problems with effervescent products—mixing...

...relevant to stability testing Stability testing Impurities Specifications LUNCH Detailed review of ICH stability testing documents ICH Q1A Defining...

...The purpose of this course is to give an overview of photostability and where it fits in the stability testing programme and the importance of photostability...

...Quality Assurance. Documentation and Technical Writing. Quality Control Laboratory. Regulatory Affairs. Qualified persons. Analytical Laboratory...

...documentation required to support OOS investigations 10.30 Morning refreshments Morning Session 2 10.45 am to 12.30pm Responsibilities Defining the...

...Regulatory agency staff requiring practical experience * Newcomers to tablet development and manufacturing * Production operators who need a better understanding...

...their importance Understanding of how PK data influences the clinical development programme An understanding of the factors that contribute to variability...

...part 1 Theory and factors affecting resolution – a reminder of the importance of resolution, separation factor (selectivity), retention factor...

...right the way through to global launch. Risk assessment methodologies are explored to help identify critical risk areas and develop mitigation strategies...