Leadership & Training
Blockchain Technology for the Life Sciences: A Comprehensive Primer0 Available
This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program0 Available
Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity. However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities. Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety. This course will give you the necessary tools to establish a working and compliant QMS for your business.
Building An Effective GMP Training System: A Risk-Based Approach0 Available
With the recent increase of job knowledge deficiencies being cited in regulatory inspections – especially in the areas of data integrity and sterile product manufacturing – training and qualification of personnel is becoming increasingly important to inspectors. Learn to define and understand the regulatory expectations around training and training systems in this webinar.
Building a Best in Class Medical Affairs Organization: Strategies for Success(1)0 Available
Medical Affairs Organizations are a growing requirement for pharma/biotech firms. However, starting them is never easy. This course will provide an overview of what great Medical Affairs organizations look like, how to build one, and where to start. This is the second session of our comprehensive nine-part certificate series.
Developing a Part 11 Compliance Plan in Clinical Research0 Available
This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works0 Available
Increasingly, global regulators want to know how effective your Corrective and Preventative Actions (CAPA) are. Investigators will look at this specifically because it will give them a comprehensive window into the steps you take leading up to measuring your CAPA effectiveness. These include Root Cause Analysis investigations, and determining CAPAs. After all, you can’t measure the effectiveness of a CAPA if the CAPA was incorrect to begin with. This webinar will show you how to measure CAPA efficacy AND ensure that you take the right steps to get to that point.
Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams(1)0 Available
Staffing for Medical Affairs (MA) teams is never easy. This course will outline what core competencies you should covet in the Medical Affairs role. These include intrinsic personality traits, experience, and more. The content will also allow you to identify and seek the qualities needed for your ideal MA to work in your specific environment.
Mock Regulatory Inspections: How to Get the Best Bang for Your Buck0 Available
Investing in a Regulatory Mock Inspection (Mock) exercise is a trending industry inspection readiness approach. Execution of a Mock based on lessons learned from industry will ensure that your inspection readiness exercise accurately identifies gaps that are truly specific to your organization, providing the most bang for your buck.
Note to File 101: Critical Steps for When – And When Not To – Engage in NTFs
How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? The intent of the note to file (NTF) is to clarify an irregularity in trial documentation or conduct, but when used too frequently or inappropriately, NTFs can highlight unresolved problems, add confusing or extraneous information, or take the place of necessary corrective action.