Urmi Quality Management Consulting Pty Ltd

As the pharmaceutical industry moves towards Pharma 5.0, it's important to understand what goes into identifying the right tool and its subsequent implementation to maintain compliance and get value. The November issue is a day early! #pharmaceutical #lifesciences #digitaltransformation #pharma5.0 #qualitymanagementsystems #compliance #gmp #leadership #qa #continuousimprovement

🚀 ARCS Australia Careers Roadshow – Stop 3 at #UQ!🚀 As the ARCS Australia #QLD Convenor, I’m thrilled to have been part of such an inspiring day! A massive thank you to our fantastic industry panelists and partners: Patrick Ling, Stuart Gibbons, Adam Stoneley, Antiksha Joshi, Megan Polidano, Daniela Sanders, Mitchell Green, Carl Bufe, Mamta Shah and Karla MacKenzie- your insights were invaluable. Grateful to Linda McConnell and The University of Queensland for their incredible support, as we continue our journey connecting with students and opening doors to the exciting world of Medtech and Pharma.🌟 #clinicaltrials #pharma #medtech #AI #ARCS #futurecareer #CPD #healthcare #pharmacovigilance Navinisha Lee

Unlock the Power of #Quality #Management #Systems ! Do you want to improve your organisation’s ability to meet #regulatory #requirements and drive #operational #excellence? Our 'Quality Management Systems – General Principles and Implementation' workshop on 06 December 2024, led by expert Antiksha Joshi, will provide practical insights into how you can enhance your organisation’s quality management practices to ensure compliance and boost efficiency. From real-world case studies to actionable strategies, this is a course designed to give you the tools to succeed in today's fast-paced #healthcare environment. Register today and secure your #earlybird discounts ➡️ https://lnkd.in/gJJ5EhNH

Are you looking to elevate your organization's operational standards? We have something you won't want to miss! Join our upcoming webinar, where life science expert, Antiksha Joshi and Ideagen's Cody Kestner explore a systems-based approach to auditing (an approach used by regulators) and the benefits it offers to improve an organization’s compliance as well as efficiency. Secure your spot today. Register via the link below ⬇️ #lifesciences #audit #regulatorycompliance

October newsletter- Focus on the "Hidden Factory" that is impacting your compliance and productivity. #quality #compliance #pharmaceutical #lifescience #medicaldevices #cdmo #clinicalresearch #biotech #continuousimprovement #gmp #qualityassurance #qualitymanagementsystem

The September issue of my newsletter is here. The focus this month is on training. Several things prompted me to share my thoughts on the subject of training within the pharmaceutical industry. 1. The FDA's Quality Maturity Model that focusses on assessing employee engagement and involvement. 2. Numerous discussions on a lack of skilled workforce. 3. My own frustration at having to read a "100" SOPs and sign off as understood as part of my onboarding. I retained nothing of what I read at the time. I learnt most of it by reading the SOP while actually performing the task. I felt it was time we rethought our approach to training and coaching within our industry. Would love to hear from individuals who have used innovative training approaches within the regulated industry and what the employee feedback has been. #trining #gmpcompliance #pharmaceuticalmanufacturing #biotech #medicaldevices #qualitymanagementsystems #quality #coaching

When should a life science (or even a medical device) startup implement a QMS program? 🤔 My answer - As soon as you are ready with your proof of concept presentation!! It may seem an overkill or excessive when one thinks of implementing a QMS program for very early stage startup, especially when there is no regulatory requirement to do so. While I agree with this sentiment partially, I would like to share my thoughts with you on this. ➡ The academic research has now moved into the translational space, where deliverables & milestones are more commercial oriented. It is important to have systems that guide the academic team on these requirements & execute their tasks consistently. ➡ Considerable amount of data & knowledge is gathered during the the early stages of development. It is important to ensure the accuracy, reliability, reproducibility & availability of this data throughout the product life cycle. QMS programs help with this. ➡ During the early stages of development, collaborations with multiple partners is common. Having systems & procedures that provide guidance on managing these collaborations enables more efficient project management. ➡ It saves time and resources when implementing QMS programs during the later stages of development (Phase 2, 3 and commercial). ➡ Tech transfer activities become easier and consistent. You do not need to establish a QA department & establish GMP compliant QMS procedures. What you need is a QMS program that is tailored for the current activities and focussed on the stage-specific deliverables/outcomes. To successfully deliver drug development projects on time, within budget & of the required quality, implementing fit for purpose QMS programs is essential. If you would like to know more, pls DM me. #drugdevelopment #lifesciences #biotech #medicaldevices #compliance #qualitymanagementsystems #gmp

It was a great webinar yesterday! We completed the Part 1 of the webinar series on Supply Chain and Outsourcing Management. Many thanks to Goh Cheong Hian (Health Sciences Authority), Antiksha Joshi (Urmi Quality Management Consulting Pty Ltd), Ricardo J. Fonseca JD, MBA (Amgen) and Paul TK Goh (Cencora). We had great time learning from you! If you miss the Part 1, don't fret, we have Part 2 on 12 Sep 2024 (1:30 PM - 4:15 PM GMT+8). Register at: https://lnkd.in/gahRV_ha Find the agenda at https://lnkd.in/g-Up-KfX

7 more days to go! We will have the first part of the webinar on 21 August. Hurry to get your slot. Part 1 (21 August 2024) registration link: https://lnkd.in/g4nbpJ3j Part 2 (12 September 2024) registration link: https://lnkd.in/gahRV_ha