ACADEMY WEBINAR PROGRAM
How to Maximize Drug Safety with Environmental and Microbial Monitoring
[ Thursday, September 14th 2023 | ON DEMAND ]
The Paperless Lab Academy® is glad to propose, under the Academy Webinar Program umbrella, a presentation from Caliber Technologies, in which they will discuss the processes and methods of avoiding and mitigating unsafe drugs with the right QC and environmental and microbial monitoring techniques.
Presenting: Rajasekhar Gollapinni, Product Excellence - Laboratory at Caliber Technologies BV
Rajasekhar Gollapinni, Product Excellence - Laboratory. A pioneer and foundational person behind the Caliber flagship laboratory solution - CaliberLIMS. Rajasekhar, with over two decades of experience in various functions at world-class companies in the pharma, petroleum, refining, and life sciences domains, now heads the laboratory product excellence. He is specialized in lab digitalization and played a key role the first paperless lab of India.
Presenting: Marc Vorderman, Director Europe Region at Caliber Technologies BV
Marc Vorderman is a Business Information Technology professional with over 25 years of experience in the process manufacturing industry (pharma, food and chemicals). He has held various senior leadership positions at international operating enterprise software vendors. Marc worked with global manufacturing and healthcare companies in Noth America and Europe, Middle East & Africa region. He is specialized in the deployment of business applications and data, for day-to-day operations and as strategic problem-solving and decision-making instruments. His areas of expertise include Business solutions, ERP solutions, human resources, customer relationship management, supply chain management, regulatory compliance solutions, data science.
Abstract
Drug safety plays a paramount importance in the pharmaceutical industry. It doesn’t stop with pharma companies facing costly litigation, 483’S, recalls, and regulatory penalties. The well-being and health of patients are compromised when drugs do not meet rigorous drug safety standards. The unsafe drug can lead to far more adverse reactions, serious health complications, or even fatalities.
With the safety of the drugs being the top priority correct environmental and microbial monitoring is crucial for drug safety in the pharmaceutical industry. It helps identify and mitigate potential contamination sources, ensuring clean manufacturing environments and minimizing the risk of microbial contamination in raw materials, processes, and finished products.
The webinar "How to maximize drug safety with Environmental and microbial monitoring" discusses the processes and methods of avoiding and mitigating unsafe drugs with the right QC and environmental and microbial monitoring techniques.
Webinar key takeaways
- Learn about the critical role of environmental and microbial monitoring in the pharmaceutical industry for ensuring drug safety.
- Learn about the potential risks associated with contamination and the need for robust monitoring practices for drug safety.
- Explore best practices and strategies for implementing effective environmental and microbial monitoring protocols in the pharma industry.
- Learn about the key guidelines, such as Good Manufacturing Practices (GMP), and the importance of aligning monitoring protocols with regulatory requirements to ensure compliance and mitigate risks.
- Explore the digital advancements in instrumentation, surface cleaning, automation for quality control in pharma lab with digital environment monitoring solution to streamline better monitoring processes and enhance data accuracy and traceability.
Deliverables
One hour free Online presentation includes Q&A session with the presenter/s
Access to the recorded session for the registrees
Who is the webinar for
- QA, QC – To ensure product quality and compliance
- R & D – Drug development and formulation in safe environments
- Manufacturing/Batch Production HOD – To oversee the entire drug production process in a clean and safe environment with no contamination risks
- Pharmacovigilance & Drug safety/Compliance team - To monitor and report adverse drug reactions, ensuring drug safety post-marketing, and conducting risk assessments will find valuable insights on how environmental and microbial monitoring contribute to drug safety.
- EM, Lab managers
Caliber is a digital GxP solution provider for the pharmaceutical industry and a pathbreaker in innovating quality-driven digital solutions for the quality and regulatory needs across the world. With over 2 decades of industry experience and 11+ world-class products and exclusive functionality, Caliber aims to support the digitalization journey of regulated companies, especially the pharmaceuticals and life sciences.
Caliber’s offerings are for process automation, quality management, data and insights and regulatory compliance. CaliberLIMS being its most demanded, the flagship product among the Caliber product suite, CaliberEMpro, the newest and the most advanced environmental monitoring addition to the QC Laboratory of Caliber.
Caliber has offers other solutions – CaliberBRM, EPIQ (Enterprise Platform for Integrated Quality), and CaliberAPQR (Anytime PQR) - one of the signature offerings and an award-winning product that has revolutionized product quality reviews. Providing products that enhance operations and transform regulated enterprises, Caliber is committed to developing more efficient, thoroughly compliant, and secure automation solutions.
Caliber Technologies BV Address - Queens Tower Delflandlaan, 1 1062 EA Amsterda, The Netherlands, (+31) 629088787