|
| Brief about the Show: |
|
| This year PharmaLytica 2012 brings for you different and convenient structure of separately bookable days revolving around techniques to deal with issues relating to regulatory lab compliance, GLP, PAT, particle size characterisation and morphology, polymorphism, analytical method development, validation and transfer and rapid microbiological techniques. This year PharmaLytica 2012 brings for you different and convenient structure of separately bookable days revolving around techniques to deal with issues relating to regulatory lab compliance, GLP, PAT, particle size characterisation and morphology, polymorphism, analytical method development, validation and transfer and rapid microbiological techniques. |
|
Who Should Visit?
|
Analytical laboratories |
|
Analytical developments |
|
Analytical services |
|
Analytical R&D |
|
Formulation |
|
Quality control |
|
Quality assurance |
|
Regulatory affairs |
|
Pharmacovigilance |
|
R&D |
|
Important Topics
|
Developing best practice strategies to overcome challenges around cGLP compliance and meet global regulatory standards with minimum time and costs. |
|
Troubleshooting complex OOS and OOT situations in the analysis through effective strategies to ensure a seamless analytical development process and swift regulatory compliance. |
|
Leveraging the latest developments in data integrity and data management to ensure 21 CFR Part 11 compliance. |
|
Adopting effective quality risk management measures to ensure consistent and high quality analytical activities, regulatory compliance and business continuity. |
|
Devising the latest techniques for efficient lab management to achieve all time lab readiness and ensure swift global regulatory compliance. |
|
Efficiently monitoring the complete testing process through Process Analytical Technology (PAT) implementation to ensure minimum time, cost and efforts. |
|
Understanding the recent regulatory standards for PAT implementation in analytical labs to ensure global compliance in minimum possible time. |
|
Understanding the reverse engineering characterisation to effectively develop formulations with better bioequivalence and improved safety. |
|
Evaluating effective measures to overcome blend uniformity challenges in formulations and establish better control on the manufacturing process through early detection and control of failures. |
|
Establishing effective techniques for method development of low dose products and modified release products to identify the gaps in the development process and overcome complex problems faced in routine analysis. |
|
|
Benefits Of Visiting
|
Strategies to overcome OOS and OOT situations |
|
Latest developments in data integrity and data management techniques – 21 CFR Part 11 |
|
CAPA – Failure investigation techniques and quality risk management |
|
Effective Implementation strategies for PAT with respect to QbD |
|
Advances in dissolution testing |
|
Reverse enginering charaterisation of formulations |
|
Other Highlights
|
Understanding related substances method development for fixed dose combinations to analyse and eliminate the inconsistencies in the development process |
|
Exploring useful techniques for analytical method validation of two drug combination low dose formulation through practical examples to achieve global regulatory compliance. |
|
Developing an effective QbD approach for reverse phase HPLC method development in formulations to understand and overcome application challenges in analytical testing. |
|
Development of discriminatory media for formulations to achieve bioequivalence with improved in vitro - in vivo correlation, accurate testing technology and swift regulatory approval. |
|
Analysing QbD approach for dissolution method development to identify the key parameters, setting specifications for routine release and developing strategies to overcome critical discrimination challenges. |
|
Analysing the application of innovative techniques for identifying and determining apt particle size in product development. |
|
Updating on the evolving regulatory requirements pertaining to accurate particle size characterisation to avoid inconsistencies and delays in achieving global regulatory approval.Understanding the current challenges faced in the use of XRD in analysis to |
|
Applying effective measures to carry out multiple transfers to multiple sites at multiple stages in the development process to ascertain enhanced method transfer. |
|
|
|
| Organizer: |
|
|
|
|
|
|
|
|
|
|
Welcome to
IndianPharma.in
|
|
