PharmaTraining courses

...for audits and audit models (overview) The Purpose of Audits Role Characteristics of the Auditor Audit Types Audit Classification Audit Methods General...

...the GMP relevant activities Assessing the rational for GMP relevance of activities Identifying the processing steps List of key documentation Identifying...

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

...Understand regulatory requirements and documentation regarding OOS investigations. Understand the critical role GMP compliance has on simplifying OOS investigations...

...Effect of binder volume on product properties Afternoon—Process Control and Process Analytical Technology (PAT) Principles of process control—feedback...

...process development or manufacturing with responsibility for the development, validation and manufacture of effervescent products. Course Overview About...

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

...and calibration – do the chambers work? Protocol development and approval Reporting stability test data Delegate Workshop Problems and issues for discussion...

...master plans 17.30pm End of day Day 2 Morning Session 1 - 9.00 to 10.30am Validation Documentation (continued) User Requirement Specification (URS)...

...arranged for large groups up to 24 staff Tutorials available for small groups of 2 or 3 staff Meet course speakers in advance to discuss design and content...

...To integrate the key elements of tablet development with hands-on, practical experience. Suitable for: Newcomers to tablet development and manufacturing...

...in PK The role of PKPD modelling in drug development An appreciation of how regulatory guidances influence PK Increased confidence to discuss PK issues...

...Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply...

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