PharmaLex’s Post

Are you ready for the DSCSA compliance deadline? The FDA stands firm on reinforcing changes to pharmacy operations starting November 2024. The impact on pharmacies is significant. Key areas affected include enhanced traceability, data management, operational adjustments, financial and logistical challenges, and risk management. At OrderInsite, we understand these challenges and are here to support your pharmacy through this transition. Our expert system delivers predictability in an ever-changing world, empowering your pharmacy to achieve its business goals. #Pharmacy #DSCSA #OrderInsite #Healthcare #Compliance #SupplyChainSecurity

The upcoming DSCSA compliance deadline in November 2024 is fast approaching and will certainly impact pharmacy operations. These changes present both challenges and opportunities for the industry. The OrderInsite team has been deeply involved in understanding these regulatory shifts and their implications so that you don't have to. Our goal is to empower pharmacies to navigate this complex landscape effectively, ensuring they can maintain their focus on delivering exceptional patient care. As we move forward, industry stakeholders must engage in conversations about how we can collectively meet these new standards and turn them into opportunities for greater efficiency and transparency in the drug supply chain. #Pharmacy #DSCSA #Healthcare #Compliance #SupplyChainSecurity

Important Update 🚨The FDA has announced that there will be NO extension to the DSCSA stabilization period. It's crucial to stay ahead of the curve and ensure your compliance with the DSCSA requirements. At VariTec Consulting, we specialize in providing the support and expertise needed to achieve DSCSA compliance efficiently and effectively. Don't wait until it's too late—reach out to us today and let us help you navigate this critical regulatory landscape. #DSCSA #FDACompliance #SerializationSolutions #PharmaceuticalExcellence #ConsultingServices #OptimizeOperations #VariTecConsulting #Healthcare #SupplyChain #Traceability #Compliance #GlobalTeam #ITConsulting #HealthcareIT #SupplyChainManagement #TechSolutions

It’s Worth the Risk - Connecting with Collaborators to Optimize Your #RBQM Risk-Based Quality Management (RBQM), is not just a best practice; it's a proactive strategy that focuses on identifying, evaluating, and mitigating risks throughout the clinical trial process in order to protect both patient safety and data integrity. RBQM allows trial #sponsors and #CROs to allocate their resources more effectively, ensuring that attention is given where it's most needed. This method not only enhances the reliability of trial results but also streamlines operations and reduces costs. For those looking to navigate the complexities of implementing RBQM or are looking to scale up your risk-based initiatives, ClinEco makes partnering easy. Connecting with seasoned RBQM specialists through ClinEco enables you to tap into expert knowledge and tailored strategies that address specific risk pain points. Leverage providers who can help you solve critical challenges, while ensuring compliance and fostering innovation in clinical trials. Join the ClinEco community today and transform your approach to clinical research with cutting-edge solutions that prioritize #safety, #efficiency, and #compliance. #clinicaltrials

Call that Quality? Really? Just had a couple of really interesting conversations at #OCTEastCoast. One with a Quality Manager from a small Pharma, the other with a CRO BD person. The QM said they'd "heard of RBQM" but wasn't actually doing anything on it. They thought their teams were handling risk using spreadsheets, but wasn't sure. They were sure that they "have lot's of spreadsheets". The CRO said that their Sponsor customers just aren't asking for RBQM so they won't offer it. It's amazing to me that we're still having these conversations. Without #RBQM and risk-based approaches, how do you demonstrate #quality in #clinicaltrials? How do you manage #risks effectively using spreadsheets? I would argue you can't. There is a much better way. Come and talk to us on Stand 64 and find out how.

𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 (𝐑𝐂𝐂-𝐌𝐃𝐑) The RCC is a leading credential for regulatory affairs professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Achieving success on the RCC exam requires knowledge of: • Conformity of the Devices • Technical Documentation • Post-marketing Surveillance • Vigilance • Clinical Investigations 📅 Deadline 𝟮𝟮 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟰 to join the next cohort to take the certification exam. https://lnkd.in/eeyj58xc #mdr #medicaldevices #ivd #ivdr #certification

It’s better to build a fence at the top of the cliff than a hospital at the bottom -Joseph Malins (1895) It can be expensive to build a strong Quality and Compliance Management System The alternative is worse Build your systems before you think you need them Because you need them from the start We help CPG brands and manufacturers build, deploy, audit, and manage Quality and Compliance Management Systems Not sure if yours is working how it should? Not sure what a Quality and Compliance Management System is? Qualitas Executive Group was built for you #quality #compliance #consulting #manufacturing #dietarysupplements #cosmetics #beautyindustry #FDA #qualitas

With the 2023 Revised USP 797 Guidelines in full effect, pharmacies are now under more scrutiny regarding environmental monitoring. However, beyond the risk of failing an audit, non-compliance can carry a multitude of costs that might be overlooked. Here’s what pharmacies should keep in mind: - Impact on Operations: When compliance issues arise, they can throw a wrench into operations. A pharmacy might face unexpected downtime or even have to pause completely. This not only disrupts workflow but also impacts patient care and the bottom line. - Damage to Reputation: Falling short of regulatory standards affects more than just the bottom line; it impacts overall trust. Pharmacies that don’t meet guidelines risk losing the confidence of patients and healthcare providers. - Additional Costs: Fixing compliance issues after they occur, from equipment upgrades to staff training, is always more expensive and time consuming than building a compliant system from the start. Staying proactive with your environmental sampling and staff training is key to success under the revised guidelines. It's always a great time to review your processes and ensure you’re meeting updated standards. #USP797 #Pharmacy #Compliance

Safety and risk management is mission-critical for every sponsor! This figure details where, when, and how MMS's comprehensive safety experts provide support. Our global team understands the regional nuances and changing regulatory requirements, as we submit to the U.S. FDA, EMA, and 25+ other global health authorities annually. Learn more and see why one head of safety at a top 10 pharma called us “absolutely wonderful.” Learn more here: https://hubs.li/Q02TN3PK0 #REMS #DrugSafety #RiskManagement

𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐆𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞𝐬 𝐔𝐩𝐝𝐚𝐭𝐞 𝐀𝐫𝐭𝐢𝐜𝐥𝐞 𝟎𝟑 𝗨𝗻𝗶𝗳𝗼𝗿𝗺 𝗥𝗲𝗰𝗮𝗹𝗹 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗳𝗼𝗿 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗚𝗼𝗼𝗱𝘀 ✓ A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.4, March 2024) has been implemented, with effect from 25 March 2024. ✓ The URPTG is for Australian sponsors who need to undertake actions (recall and non-recall actions) for therapeutic goods in Australia. ✓ It outlines the processes to respond efficiently and effectively to problems with therapeutic goods that could pose a risk to public health and safety. ✓ It also explains the roles and responsibilities of all stakeholders who are involved in therapeutic good recalls. ✓ This version includes the following updates: 1. Additional clarity on the requirements for immediate recalls. 2. Removal of the requirement for monthly compiled lists of Single Donor Notifications from the Australian Red Cross Lifeblood 3. New information on the ‘Early Advice’ process. 4.Clarification on the timing for release of recall information by us. 5.Refined recall reporting requirements, including more flexible timeframes and removal of the 2-week report. 6.Additional clarity around the definition of Class III recall actions, including a guide for estimating the classification. 7.Additional clarity on the requirements for customer acknowledgement forms. 8.Removal of the recall action document templates. 9. Clarification concerning the TGA and ACCC ‘lead regulator’ roles for recalls of therapeutic goods that are also consumer goods 10. Removal of outdated guidance, such as information concerning addressing letters, labelling envelopes and submitting notifications via email. 11. Minor editorial amendments. Step wise Procedure for Recall and Non-Recall Actions; Step 1 Obtaining distribution and stock status Step 2 Conducting a risk analysis. Step 3 Deciding the type, class, and level of your action Step 4 Developing an action strategy Step 5 Drafting a communication strategy Step 6 Submitting the notification Step 7 TGA assessment of your proposed action Step 8 Implementing the action Step 9 Reporting on the action Step 10 Reviewing the action The TGA will review the progress reports and decide if any further actions are required. #recall #TGA #learning #GMP #Pharma #QMS #healthcare #qms #qa