Flavorchem Corporation’s Post

I’m looking forward to learning, meeting peers, catching up with colleagues from Thermo Fisher Scientific and other companies, and more at this year’s Pharma Manufacturing World Summit (PMWS24) this week in Boston. I’ll be hosting one of the event’s “Themed Lunch” discussions on Tuesday, May 14 from 12:45 p.m. to 1:45 p.m., where I’ll share my six-step path for “Changing the Compliance Paradigm in Large, Global Companies” and facilitate a small group discussion on the topic, where I know I’ll learn from other perspectives and insights. #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #AI #PMWS24 #pharmamanufacturing #compliance

Regulatory Science at CDER Read more: 👉https://ow.ly/js0750Qt7ra CDER's regulatory science activities are aimed at speeding the development of new drugs while ensuring that they are safe and effective. 𝗖𝗹𝗶𝗰𝗸 𝘁𝗵𝗲 𝗹𝗶𝗻𝗸 𝗮𝗯𝗼𝘃𝗲 𝘁𝗼 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝗿𝗲𝗮𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗹𝗮𝘁𝗲𝘀𝘁 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗖𝗲𝗻𝘁𝗲𝗿 𝗳𝗼𝗿 𝗗𝗿𝘂𝗴 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵.

Discover the future of sterile compounding! Our August 14th webinar will explore the critical components of a compounding compliance program. Gain insights into innovation, automation, and data-driven decision-making from leading experts in the field. Save your seat here> https://ow.ly/1wVJ50SL6yZ #Sentri7 #IVWorkflow #Webinar #Pharmacy

Are you engaged in any drug manufacturing activities? Are you wondering how to preserve regulatory compliance while at the same time securing flexibility and scalability of operations? Are you looking for a modern tool that enables modeling your processes and supports their execution? If your answer is “yes” to any of the former questions, then join us on February 21, 2024 at 16:00 Central Europe Time. Use the link below to register today! #lifesciences #manufacturing https://lnkd.in/eZsmaSMz

Discover the future of sterile compounding! Our August 14th webinar will explore the critical components of a compounding compliance program. Gain insights into innovation, automation, and data-driven decision-making from leading experts in the field. Save your seat here> https://gag.gl/Z9nCG7 #Sentri7 #IVWorkflow #Webinar #Pharmacy

Struggling with Compliance? Is #compliance feeling like an overhead? Is it adding stress, slowing down your #manufacturing, and inflating #costs? 😰 We get it. But it doesn't have to be this way. At PharmaX, we believe compliance should work for you, not against you. That's why we've developed a #pragmatic approach to compliance that is easy to follow and ensures you're always in the clear. ✨ Meet Tim and Pat ✨ – the newest members of PharmaX, who will be discussing the daily challenges faced on the manufacturing and compliance. From navigating complex regulations to ensuring seamless operations, they're here to share insights and practical solutions. Want to learn more? Let's connect and explore how PharmaX can help you achieve compliance the smart way. Email us at [email protected] #PharmaXSolutions #PharmaX #Compliance #Manufacturing #Consulting #PharmaIndustry #ComplianceSolutions #Services #Lifesciences #Smartmanufacturing

Having just finished reading “Bottle of Lies” by Katherine Eban, I have to say it was the single most eye-opening book I’ve read in years. For those who haven’t read it, the author, an investigative journalist, reports on overseas generics manufacturing in countries such as India and China, and the fraudulent practices some companies engage in (e.g., fabricating bioequivalence data, substituting brand named drugs for generics during testing, and covering up quality issues in their production batches) to get their drugs approved by regulators for marketing in the US. The implication for patients is obviously dire, especially when the prevailing thought is that generic drugs are cheaper, yet clinically equivalent, versions of their branded counterparts, offering a win-win alternative for patients. It offers a compelling case of the scrutiny that pharma companies and drug regulators need to place on drug suppliers. Being a consultant primarily within the Life Sciences, I’m always interested in takeaways that could be helpful to potential clients. As such, three major business themes came to mind that I thought worth sharing: 1) You measure what’s important to you. And necessarily, if it’s not important to you… you don’t measure it. This is relevant for performance management, at the individual level and at the group level. A simple example: if an employee is evaluated exclusively on the number of batches that go out the door, then you rely on an employee’s integrity to prioritize a potential patient’s health when they discover a quality issue, especially when rejecting a drug batch works against the metrics against which they are assessed. 2) Audits work… when done right. In highly regulated industries, audits serve as a powerful tool to ensure compliance. In the absence of intrinsic motivations to create and ship high quality products, the threat of being caught, fined, or even prosecuted serves as a good extrinsic motivator. In the book, the best audits shared two qualities: a) they were unannounced (or gave minimal time for manufactures to hide unsavory data or practices), and b) they were led by competent investigators (auditors need to be better at uncovering evidence than bad actors are at hiding it). 3) Company values matter. Values, principles, or North Stars, in my opinion, all serve the same tactical purpose - biasing action towards a particular outcome, especially in ambiguous and time-sensitive contexts, such as one that an operator might face on a shop floor. In the book, a company whose stated North Star was to achieve X Bn in revenue in a particular year, did not fare so well when auditors came knocking, versus a company whose stated value was patient safety above all. Curious to hear other people’s thoughts and key takeaways, either on the book or best practices for compliance! *All opinions are my own and do not represent my firm’s.*

Glemser is gearing up for DIA's RSIDM Forum 2024 💪 We'll be delving into AI and automation's role in optimizing the quality and generation time for ePI conversions and other regulatory submissions. Explore the full agenda for insights into our session and join us for enriching discussions! ➡️ #Pharma #LifeSciences #StructuredContent #Compliance #ContentCompliance #Labeling #RegulatorySubmissions

Where the ink hits the paper.    Where theory turns into practice.    Where the hammer meets the nail.    Where the gears mesh.    Where the needle meets the groove.    Where the words turn into action.    Where the plan meets reality.    Where the spark ignites the fuel.    Where the rubber meets the road.    Where the proof of the pudding is in the eating.    Where the actions are the true test of character-    This is where it all comes together- RxLogix Drug Safety Platform

Discover the future of sterile compounding! Our August 14th webinar will explore the critical components of a compounding compliance program. Gain insights into innovation, automation, and data-driven decision-making from leading experts in the field. Save your seat here> https://gag.gl/Z9nCG7 #Sentri7 #IVWorkflow #Webinar #Pharmacy