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 Drug Product Submission (NDS) Preparation in CTD and eCTD Format Workshop- Level 3 May 30 | 2:00 PM - 4:00 PM (EST) (Online) Mergers & Acquisitions (Due Diligence to Execution) - A Regulatory Perspective Jun 5 | 2:00 PM - 3:00 PM (EST) (Online) Navigating the USP: Practical Guidance for QA. QC & Industry Professionals Jun 18 | 2:00 PM - 3:00 PM (EST) (Online) Are you ready to expand your learnings? Broaden your knowledge and delve into new horizons with AAPS! LEARN MORE!

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Master Computer System Validation (CSV) – Join Our Upcoming Workshop!

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Greetings! AAPS Pharma is pleased to announce an upcoming workshop focused on Computer System Validation (CSV), a crucial regulatory requirement for the healthcare industry. Mandated by Health Canada, the FDA, and the European Union, CSV ensures that all computerized systems or automated data processing systems in healthcare (including pharmaceuticals, medical devices, logistics, and warehousing) are validated for their intended use according to pre-defined protocols before being put into production. This workshop provides a comprehensive introduction to CSV and its regulations, offering participants the foundational knowledge required for day-to-day operations in regulated industries. Throughout the workshop, participants will gain valuable insights into the principles of CSV, including an in-depth exploration of GAMP®5 and the critical role it plays in system categorization. Key topics include the System Development Life Cycle (SDLC), the V-Model Approach, and the essential validation deliverables such as requirements documents, validation plans, and test reports. Additionally, the workshop will cover 21 CFR Part 11 compliance and the regulatory landscape surrounding CSV in both the FDA and international markets. Through practical application and real-world case studies, attendees will learn the competencies needed to ensure efficient, effective, and inspection-ready validation initiatives. This workshop is ideal for professionals in the healthcare industry responsible for the validation of computerized systems. It is particularly beneficial for those in quality assurance, regulatory affairs, IT, validation engineering, and compliance roles. It also offers immense value to individuals involved in developing, implementing, or overseeing validation protocols and procedures. By the end of the session, participants will have a deep understanding of the regulatory requirements surrounding CSV, the SDLC, and best practices for validation deliverables, all while ensuring ongoing audit readiness and compliance. Join us to gain the expertise required to navigate the complexities of computer system validation and ensure your systems remain compliant with the latest regulatory standards. Date & Time Jun 26, 2025 1:00 PM - 4:00 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 416-628-7575 or email us at events@aapspharma.com

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Navigating the Complexities of Mergers & Acquisitions: A Regulatory Affairs Workshop

Learn how to manage regulatory risks and ensure compliance throughout the M&A process in the medical and pharmaceutical industries.

Greetings! We are excited to introduce an upcoming workshop that explores the critical role of Regulatory Affairs in mergers and acquisitions (M&A), particularly within the medical technology, pharmaceutical, and biopharmaceutical industries. As companies seek to expand their product portfolios, market presence, or enter new markets, M&A activities become a key strategy. However, these processes involve numerous regulatory considerations, making it essential to understand the regulatory landscape for successful execution. This workshop will provide a deep dive into the regulatory factors that impact M&As, focusing on due diligence, regulatory requirements for execution, and post-acquisition integration. The session will highlight the importance of ensuring compliance and mitigating risks throughout the M&A process. It is tailored for professionals in Regulatory Affairs, Compliance, Legal, and Project Management, as well as those in Finance, Marketing, R&D, and Operations who are involved in or supporting M&A activities. Consultants and stakeholders engaged in strategic business expansions will also benefit from this session. Key topics covered will include the critical success factors for M&As, key regulatory considerations in due diligence, risk evaluation and mitigation strategies, regulatory requirements for M&A execution, and essential decisions for effective post-acquisition integration. Participants will leave with the knowledge needed to navigate the complexities of M&A in a regulated environment, ensuring a successful regulatory plan from due diligence to integration. Join us to enhance your understanding and gain valuable insights into the role of Regulatory Affairs in M&A activities. Date & Time Jun 5, 2025 2:00 PM - 3:00 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 416-628-7575 or email us at events@aapspharma.com

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Master Advanced Batch Record Review Techniques – Join Us for Level 2 Workshop

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Greetings! We are pleased to invite you to Level 2 of the Batch Record Review workshop, where we will dive deeper into the more complex aspects of GMP compliance. This session is designed for professionals looking to enhance their skills in handling variances, deviations, and out-of-specification (OOS) results in batch records. During this workshop, participants will learn advanced techniques to evaluate critical discrepancies, conduct detailed investigations, and apply Corrective and Preventive Actions (CAPA) effectively. Additionally, the workshop will cover best practices for reviewing analytical data and technical documentation, ensuring both product quality and full regulatory compliance. This workshop is ideal for professionals who already have experience in batch record review or have attended Level 1. It will be particularly beneficial for quality assurance (QA) professionals, regulatory compliance specialists, and anyone involved in in-depth batch record analysis, especially when addressing deviations and OOS investigations. Throughout the session, you will master advanced techniques in batch record review and gain practical knowledge on investigating variances and handling discrepancies. You will also explore how to review analytical data and technical documentation within batch records, with a focus on ensuring compliance with Good Manufacturing Practices (GMP). The workshop will also guide you on how to implement CAPA in response to batch discrepancies, helping you maintain a continuous improvement cycle and meet regulatory standards. This session promises to equip you with the tools and strategies necessary to handle complex batch record reviews with confidence. If you're looking to advance your expertise and deepen your understanding of GMP compliance, this workshop is an invaluable opportunity. Date & Time Jun 19, 2025 2:00 PM - 4:30 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 events@aapspharma.com

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Join Our Upcoming Webinar: Mastering the United States Pharmacopeia (USP)

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Greetings! Navigating the United States Pharmacopeia (USP) can be a challenging task for professionals within the pharmaceutical, cannabis, and herbal drug industries, especially for those without prior experience. This webinar is designed to simplify the complexities of the USP, offering clear, actionable guidance for quality assurance reviewers, quality control chemists, recent science graduates, and industry professionals who wish to deepen their understanding of this vital resource. During this session, we will break down key sections of the USP, including general chapters, product monographs, reagents, indicators, solutions, and general notices. We’ll also explore the structure and application of the USP, allowing attendees to navigate it with confidence. To bring the concepts to life, real-life case studies will be reviewed, offering practical examples of effective documentation review. By the end of the webinar, you’ll be equipped with the tools necessary to apply USP standards accurately in your daily operations. This webinar is ideal for anyone involved in ensuring product quality and regulatory compliance within the pharmaceutical, cannabis, or herbal drug sectors. Whether you're a quality assurance reviewer, a quality control chemist, or a new graduate entering the science field, this session will provide valuable insights that will enhance your professional skills and knowledge. Participants will gain a comprehensive understanding of USP’s structure, including its chapters and monographs, and will be better prepared to apply these standards to real-world scenarios. You’ll also learn how to interpret and use key components like reagents and solutions, while gaining a deeper understanding of the general notices and requirements that shape industry practices. Through case studies and practical exercises, attendees will refine their ability to navigate the USP and enhance their effectiveness in documentation review. Don't miss this opportunity to improve your proficiency in USP navigation and streamline your work processes. We look forward to seeing you there and helping you take the next step in mastering USP standards. Register Now to Secure Your Spot! Date & Time Jun 18, 2025 2:00 PM - 3:00 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 416-628-7575 or email us at events@aapspharma.com

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