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.
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.
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.
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.
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.
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.
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.
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.
Pharmaceutical and Biotech Clinical R&D and Pharmacovigilance (PV) Subject Matter Experts (SMEs) are often in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for many employees, particularly those in middle management. The top inspection readiness priority is to avoid observations by preparing on various levels. This is great! However, audits and inspections do result in observations for many companies. With the increasing number of life sciences companies – and vendors that support them – training on how to develop and write an appropriate Corrective and Preventative Action Plans (CAPAs) is critical. Don’t find yourself beautifully prepared for your audit or inspection, yet unprepared for the aftermath. Join this webinar to learn best practices for preparation.
