Overview A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with...

The Event: Think you're up for the challenge? Check out this unique, one-day-only puzzle event where you'll be competing against 20 other teams to see if you and your...

Canadabiz website serves Internet users with the most accurate business information available online. Now we decided to expand and prepared a set of practical workshops...

Overview: It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance. Areas Covered in the Session: Which...

Overview GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national...

Securing Business Critical Applications on Microsoft Azure Join us in Burlington at the Microsoft Technology Center for an interactive discussion around common deployment...

Securing Business Critical Applications on Microsoft Azure Join us in Burlington at the Microsoft Technology Center for an interactive discussion around common deployment...

Overview Personnel in the Pharmaceutical manufacturing will be asked to write and review many different documents. These documents are important, in that, it will be scrutinized...

Course “Analytical Methods Validation for FDA Compliance “ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full...

Overview: Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events...

Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to...

Overview This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides...

Overview With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding...

Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend:...

As scientific breakthroughs and novel discoveries reveal the causal link and interface between metabolic pathways and immune cell function, the inaugural Immunometabolism Drug...

Overview: You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials. Areas Covered in...

Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory,...

Overview After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and...

Overview: This ISO 13485:2021 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and...

Overview After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and...

Description The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2021. From that date, manufacturers, suppliers,...

Description The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2021. From that date, manufacturers, suppliers,...

Course “Analytical Methods Validation for FDA Compliance “ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full...

Description The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2021. From that date, manufacturers, suppliers,...

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. The new Medical Device Regulations (MDR)...

Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System...

Overview The Harmonized Tariff Schedule (HTS) is used by over 200 countries, territories, or customs unions around the world to assign a number to each product to establish the...

Overview The Harmonized Tariff Schedule (HTS) is used by over 200 countries, territories, or customs unions around the world to assign a number to each product to establish the...

Description Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your...

Returning to Boston in February 2020 is the 8th Neurodegenerative Drug Development Summit, previously World CNS. Despite the lack of clinical trial success, new investments are...