Your Weekly Event Guide: Expand Your Learnings and Discover Exciting Opportunities

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Discover the top events for you in our Weekly Event Guide OOS Investigations for Testing Laboratories in a GMP Environment May 9, 1:00 PM - 5:00 PM (Online) Drug Product Submission (NDS) Preparation in CTD and eCTD format May 16, 9:00 AM - 5:00 PM (Online) Computer System Validation (CSV) - Introduction to General Principles May 23, 1:30 PM - 4:30 PM (Online) Are you ready to expand your learnings? Broaden your knowledge and delve into new horizons with AAPS! LEARN MORE!

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LAST CALL: Dive Deep into OOS Investigations – Learn from Our Expert Instructor!

Experience interactive learning and expert guidance in GMP compliance – Secure your seat now!

We're thrilled to extend an invitation to join us for a transformative workshop on "OOS Investigations for Testing Laboratories in a GMP Environment," hosted by Terry Pilkey, a seasoned Quality Assurance and Quality Control professional with over 30 years in the pharmaceutical industry. 📽️ Watch the Reel to Hear Directly from Terry Pilkey! 📽️ Event Highlights: Insightful Discussions: Delve into FDA guidelines and regulatory observations with Terry. Interactive Learning: Engage in hands-on exercises and real-world case studies designed to enhance your investigative skills. Networking Opportunities: Connect with industry peers and discuss the challenges and solutions in OOS investigations. Why Attend? Gain invaluable skills to ensure your lab remains compliant with evolving regulatory expectations and master the intricacies of OOS investigations in a GMP environment. Event Details: Date: May 9th Time: 1:00 PM to 5:00 PM Location: Online Don’t miss out on this opportunity to advance your career and ensure excellence in quality control. REGISTER NOW

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Join Our Webinar: Mastering Regulatory Strategy for Healthcare Products

Gain expert insights on May 30th – Secure your spot now!

Greetings! We are excited to invite you to our upcoming webinar, "Regulatory Strategy - Medical Devices and Other Health Technologies," taking place on May 30, 2024, from 1:00 pm to 2:30 pm (EST). This expert-led session will explore the intricate landscape of Regulatory Affairs and the necessity of a clear and effective strategy in the development and management of healthcare products. Leading the session are seasoned professionals in the field, Arthur Kawasaki, M.Sc., MBA, and Kandarp Shah, Ph.D., RAC. Arthur brings over 29 years of experience across various sectors including pharmaceuticals and medical devices, having held senior roles at renowned companies like Eli Lilly and Exact Sciences. Kandarp offers a depth of knowledge in US regulatory approvals and international registrations, complemented by a strong research background in biological sciences.  This session is particularly designed for regulatory affairs professionals, product development teams, quality assurance personnel, and other key decision-makers in the medical device, in vitro diagnostic, and pharmaceutical industries. Participants will gain a thorough understanding of differentiating between Regulatory Strategy and Regulatory Plan, identifying critical inputs, and developing a robust Regulatory Strategy. LEARN MORE Each participant will receive a certificate of attendance upon completion of the webinar, along with comprehensive course materials to support ongoing learning and application. We encourage you to register by May 23, 2024, to secure your spot in this essential webinar that promises to enhance your capabilities in navigating the complex regulatory environment effectively. Date and Time: May 30, 2024 1:00 PM - 2:30 PM (EST) How is the webinar delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY! Interested in this webinar? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

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Master Drug Product Submission: Join Our NDS Preparation Workshop

Elevate your expertise in CTD and eCTD formats

Greetings! We are excited to announce an upcoming workshop that promises to be a cornerstone for professionals in the pharmaceutical industry- a comprehensive workshop on "Drug Product Submission (NDS) Preparation in CTD and eCTD format." This online event is scheduled for May 16, 2024, from 9:00 am to 5:00 pm (EST), offering an invaluable opportunity for industry professionals to deepen their understanding and expertise in drug product submissions. REGISTER TODAY! Participants will gain in-depth knowledge of Health Canada's guidance documents for preparing new Drug Submissions (NDS), which is critical for those involved in the preparation of chemical drugs, biologicals, biopharmaceuticals, biosimilars, and chemical generics. The workshop will cover essential areas such as Chemistry Manufacturing and Controls (CMC), Nonclinical, and Clinical aspects within the ICH CTD module format. Attendees will also have the chance to engage in practical exercises by working on a mock submission binder, providing hands-on experience that is directly applicable to their professional roles.  This workshop is particularly suited for individuals in regulatory affairs, quality assurance, product development, and other related fields within the pharmaceutical and allied industries. It is an essential learning opportunity for those looking to enhance their skills in NDS submission, CTD module navigation, eCTD implementation, and practical submission preparation. LEARN MORE In addition to the knowledge and skills gained, participants will receive a certificate of attendance and a specially prepared course manual, serving as valuable resources for continued learning and reference. We encourage all interested members to register online as soon as possible, as registration closes on May 9, 2024. This workshop represents a unique opportunity to stay at the forefront of industry standards and regulatory requirements, enhancing your professional expertise and contributing to your organization's success in drug product submissions. Looking forward to your active participation. Date and Time: May 16, 2024 9:00 AM - 5:00 PM (EST) How is the workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY! Interested in this workshop? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

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