iPharmaWorkshop is an international training provider of high-quality courses based on the latest published technical and regulatory requirements. We provide customised training to provides virtual & in-person workshop, with maximum employee interaction. These sessions are always conducted as per requirement of client for detailed discussion on the topic in question.
iPharmaWorkshop strongly believes that workshop training is most effective when it is directly relevant to the activities performed by the attendees. With that in mind, our company likes to work closely with you to design courses that your staff can immediately relate to and that answer their specific questions.
We always work on “Walk to Talk” ideology goes beyond the content at the conferences we produce to the individual experience at each event and our commitment to ensure that all attendees feel welcome and represented.
This workshop provides an optimistic platform for exchanging ideas and helps the attendees to get updated about the advancements and innovations in the pharma Industry. Take a chance and make it count in your professional life, attend various iCretegy Summit which is the best platform to network with your peers, exchange expertise and experiences, and arm yourself with the latest information to take your department to the next level. Please see attached PDF for more information.
Topics under this workshop which include (but not limited to):
| IQA Workshop | • Integrated Quality Assurance: “Concept, Plan, Execution, Implementation” (“Experienced from Past” – “Apply in Future”): • Peer Review of NDA/ANDAs by all disciplines for faster approval & launch on-time |
| Maximum Utilization of GDUFA III Awareness Workshop | • What’s new, what will it mean to your company, how industry reacts. How you take benefits as well as current update from FDA’s, budget planning, goal dates, how to accelerate your approval by understand the FDA requirement and business benefits. |
| FDA Now | Act Now, Stay Informed Summit | • To better understand the FDAs current working scenario expectations and provide a 360 view, minimize the Def, launch readiness. Industry movement & competitions. Early ROI by capturing % market share. |
| NO MAJOR CR Workshop | • Way to identify the Major deficiencies and enabling applicant to prepare the mitigation plan before Regulatory submission. • Early find and resolve Major CRs saves 15-24M approval time to company which will be indirect $Synergy from late launch. • Company can work ‘Proactive’ to resolve Major Issue before 1st DRL (Mid Cycle Review). • This also helps for FDA inspection (PAI/cGMP) readiness |
| GDUFA III DMF Now | Act Now- Stay Tuned Workshop | • DMF Assessment Program Enhancements are introduced as part of GDUFA III, effective from Oct 1st, 2022. • Consider DMF as one of the major focus areas, for the success of our projects, a company should know FDA facts under GDUFA I & II and apply to GDUFA III. • GDUFA III offers a prior assessment of API DMF, 6-month prior to the ANDA filing, if your ANDA qualifies as per specified conditions. • This will help to understand the company in terms of ‘How can we strengthen the Open Part DMF review’ to get the straight approval and work with DMF vendor proactively to resolve early DMF deficiencies before DRL receives to applicant. |
| Reduce Human Error Summitt: | • Reduce Human Errors in QC’s, Ops & QA’s from batch processing to testing. The workshop will help prepare MaPP from a culmination of >2 years of Analyst, Supervisors and Manger feedback, review of all OOS and lab deviations from last 3 years, which helps your HE by 75%. |
| Introspect on Investigations: | • Workshop will help to reduce NOIs, Customer Complain etc.. One NOIs brings ‘Risk for Compliance’, ‘Time to Close Investigation’, ‘Resources’ (Material, Man, Machine, lab testing), Stability cost and $ (FTS, Discard batches, impact on Revenue) and much more.. •This workshop brings s awareness from PACA to CAPA. • Through this workshop company can evaluate, the Gaps & Challenges. Each of team will present the ‘Action Plan’ to overcome minimize OOS in future |
| Department Annual Meet Workshop Inspire – Integrate – Innovate | •From understanding company goals to execution and HOLD department to be accountable. • This will also help inter department team to explore the ideas to align with company’s mission, vision and success plan to meet HR performance goals |