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Wednesday, April 24, 2024

🎉 Alumni Success Stories: Meet Henry! 🎉

Greetings!

Meet Henry Vu, a standout CRA '23 graduate from AAPS, who is now making significant strides in the pharmaceutical industry as a QC Lab Specialist/Lab Documentation Specialist at BioPharma Services. Before joining AAPS, Henry completed his Bachelor of Science at the University of Toronto but found himself lacking the practical experience necessary to secure a position in the pharmaceutical field. AAPS bridged this gap for Henry through targeted courses that enhanced his understanding of fundamental research and development processes.

Discover more about Henry's inspiring story in this video!

During his studies, Henry leveraged the AAPS Career Services to secure an internship at BioPharma Services, which provided him with invaluable industry experience. This internship paved the way for a full-time position shortly after his graduation. Throughout his journey from the classroom to his current role, the AAPS team provided continuous support, something Henry credits as integral to his success in the fast-evolving pharmaceutical industry. Now, with a career well underway, Henry continues to emphasize the importance of ongoing learning and growth, drawing on insights from seasoned industry professionals.

For those contemplating a career in pharmaceuticals, Henry’s experience illustrates how AAPS can be the catalyst for significant professional development and success.

Learn more about AAPS!

Interested in AAPS?

🔑 Your Guide to Computer System Validation - Meet Our Instructor

Greetings!

We are thrilled to introduce you to Krishnachaitanya Pabbaraju, the instructor for our upcoming event, Computer System Validation (CSV) – Introduction to General Principles.

The virtual event is scheduled for May 23, 2024, from 1:30 pm to 4:30 pm (EDT).

Mr. Pabbaraju is a seasoned CSV professional with over a decade of experience in validating Computer Systems and Quality Systems across various industries including pharmaceuticals, medical devices, biotechnology, and healthcare logistics. His expertise encompasses a broad range of areas, from GXP, 21 CFR Part 11, Annex -11, to GAMP 5 compliance in both validation and quality domains. With a strong focus on improving compliance and efficiency, he has played a pivotal role in validating ERP systems, Quality Management Systems, Lab Information Management (LIMS), and more.

Presently, Mr. Pabbaraju occupies a prominent leadership role within a healthcare logistics firm, spearheading the integration of state-of-the-art technological advancements to elevate both quality and compliance protocols. With his wealth of experience and commitment to excellence, he is the ideal guide to help you navigate the intricacies of Computer System Validation and its critical role in the healthcare industry.

Join us for the insightful session led by Mr. Pabbaraju. Gain unparalleled insights into the world of Computer System Validation and its pivotal importance in regulated healthcare sectors.

Date and Time:

May 23, 2024

1:30 PM - 4:30 PM (EST)

How is the webinar delivered?

Live. Interactive. Instructor-led.

Interested in this webinar?

Tuesday, April 23, 2024

Master Drug Product Submission: Join Our NDS Preparation Workshop

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.

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.

Interested in this workshop?

Join Our Webinar: Mastering Regulatory Strategy for Healthcare Products

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.

Interested in this webinar?

National Costume

Wednesday, April 24, 2024

🎉 Alumni Success Stories: Meet Henry! 🎉

🔑 Your Guide to Computer System Validation - Meet Our Instructor

Tuesday, April 23, 2024

Master Drug Product Submission: Join Our NDS Preparation Workshop

Join Our Webinar: Mastering Regulatory Strategy for Healthcare Products

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