Regulatory submissions are a cornerstone of the pharmaceutical industry, and mastering this process is essential for regulatory affairs professionals. On November 8, 2024, AAPS hosted an insightful webinar on Drug Product Submission (NDS) Preparation in eCTD format. The webinar aims to equip participants with practical knowledge and skills for successful submissions. Here are the four key takeaways from this dynamic event. 1. Understanding the Importance of the Common Technical Document (CTD) One of the standout segments of the webinar focused on the Common Technical Document (CTD), a globally standardized format for regulatory submissions. Participants learned how the CTD facilitates organization.. READ MORE »
Are you a quality assurance professional seeking to enhance your expertise in regulatory standards? Don’t miss our upcoming webinar on November 28, 2024! We’ll dive deep into the United States Pharmacopeia (USP), demystifying its complex structure and providing practical guidance for its effective use. Whether you’re a seasoned quality assurance reviewer, a quality control chemist, or a new science graduate, this webinar will equip you with the knowledge you need to navigate the USP confidently and accurately. Why Attend This Webinar? The USP is a critical resource for professionals across the pharmaceutical, cannabis, and herbal drug industries, setting standards to.. READ MORE »
Canada’s commitment to building a highly skilled workforce includes the Canada-Ontario Job Grant (COJG), a valuable resource for pharmaceutical industry employers looking to invest in developing their teams. Through COJG, companies can access high-quality pharmaceutical training for their employees at our pharmaceutical institute, AAPS. This helps employers keep their teams at the forefront of industry standards. For pharmaceutical companies, COJG offers a cost-effective path to upskill employees, enabling teams to enhance their knowledge and adapt to the industry’s evolving needs. Here’s how this grant supports employer-driven team development. What is the COJG? The Canada-Ontario Job Grant (COJG) program provides financial.. READ MORE »
Are you a pharmaceutical quality assurance professional seeking to strengthen your expertise in out-of-specification (OOS) investigations within testing labs? This critical area of QA can be challenging yet essential for ensuring product quality and regulatory compliance. Join us on November 14, 2024, for a comprehensive workshop on mastering OOS investigations explicitly designed for professionals like you. Why This Workshop Is Essential OOS results are a top priority for regulatory authorities. When test results fall outside predefined specifications, it’s not simply a “red flag” but a call for immediate and thorough investigation to maintain product integrity and regulatory compliance. Effective OOS.. READ MORE »