Want to work in Regulatory Affairs? Get trained on CMC today!

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Greetings! The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will gain an understanding of the CMC portion of a Common Technical Document (CTD) which is the format that regulatory submissions in Canada and the EU must be filed. LEARN MORE Course Outline The following specific topics will be addressed in detail: Role of CMC in drug development Nomenclature and characterization of drug substance Analytical methods and validation Manufacturing, in-process controls and process validation Developing drug substance and drug product specifications Stability, stability-indicating tests and how much change is acceptable Regulatory expectations for product characterization Drug Master Files Structure, content and components relating to CMC section of a regulatory submission LEARN MORE Date and Time: March 17, 2023 9:00 AM - 5:00 PM (EST) How is the webinar delivered? Online. Live, interactive, instructor-led GET CERTIFIED TODAY! Interested in this workshop? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca. Academy of Applied Pharmaceutical Sciences

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How to Write Effective Standard Operating Procedures (SOPs)?

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Greetings! Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. SOPs provide the main forum for the documentation of a Company’s systems, processes and operations.  SOPs are therefore the most popular documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices that follow regulatory requirements and they are followed as written. LEARN MORE Course Outline This workshop will have discussion on topics like:  What is an SOP? Why do we need SOPs? When do we need SOPs? Roles and Responsibilities Sections of an SOP Writing Tips How SOPs are Written Change Control Maintenance SOP Workshop LEARN MORE Date and Time: March 14, 2023 2:00 PM - 4:00 PM (EST) How is the webinar delivered? Online. Live, interactive, instructor-led GET CERTIFIED TODAY! Interested in this workshop? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca. Academy of Applied Pharmaceutical Sciences

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Coming Soon: Annual GMP Masterclass

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GMP Fundamentals Webinar 2 WEEKS TO GO! Curious about how Good Manufacturing Practice can help you in making informed decisions to improve your strategy and return on investment?  Don’t miss our Live Webinar GMP Fundamentals! You will gain practical knowledge in understanding the essential elements and quality systems required for GMP and for maintaining compliance in the pharmaceutical industry. Who Should Attend? Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices, etc.  LEARN MORE  Course Outline Assuring Quality in the workplace The benefits of GMP compliance Management Responsibilities for GMP SISPQ/principles of drug production AND MORE...   Date and Time: March 09, 2023 2:00 - 4:00 PM (EST) How is the webinar delivered? Online, Live, Interactive, Instructor-led GET CERTIFIED TODAY! We hope you'll be joining us to begin your journey to land your dream job! Start your application by calling our enrollment team at 416-502-2277 or sending us a direct inquiry at info@aaps.ca Academy of Applied Pharmaceutical Sciences

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State of Pharma Conference: Last Week of Early Bird Discount

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The State of Pharma (SOP) conference will provide a premier interdisciplinary platform for researchers, practitioners, and representatives from governing bodies to present and discuss the most recent innovations, trends, concerns and practical challenges impacting the pharmaceutical industry at this very moment. From decision-making regulators actively shaping the future of the industry, to business leaders at the forefront of innovation - this is the most crucial platform for those looking to navigate, and learn directly from industry leaders. Secure your seat today to avoid missing out and stay tuned for our next announcement to get updates on the full lineup of speakers and agenda! Heather Longden is an independent regulatory compliance consultant to the pharmaceutical industry. Heather specializes in data integrity, regulatory compliance, data management, GLP and GMP and computer system validation. She acts as an advisor to various regulatory groups, specifically as a leader at GAMP® Americas steering committee and serves on the the ISPE Boston Area Chapter Board and Education Program Committee (EPC). The final agenda for The State of Pharma has been released and we're excited to be bringing you a day-long program containing in-depth discussions on a wide range of topics related to the pharmaceutical industry.    On May 11th, we will address current challenges and potential solutions within the industry and touch upon the areas of regulation, innovation, and much, much more.  View the full agenda today.  We are inviting a limited number of organizations to join as Sponsors of the event. For more information or to express an interest please reach out to info@aaps.ca. TICKETS       BUY NOW       SPONSOR       CONTACT US

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