Upcoming Live Courses
Applying Six-Sigma Tools and Concepts in Clinical Research – A Process Improvement Guide0 Available
Six Sigma is a well-known certification within the manufacturing world, but it’s concepts and practices that can easily be applied to routine activities in clinical research. This course will introduce you to several tools that have been recognized in Six Sigma certification training. The curriculum will demonstrate how simplified, modified versions of these tools are already in use, and guide you on identification and use. Upon completion, you will have actionable, practical Six Sigma tools to bring to bear on your clinical operations – from Sponsor to Site.
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions0 Available
Initial activities surrounding Event Investigations (investigations cause by the result of a deviation which lead to root cause analysis and eventual corrective action) are often neglected – or poorly executed – by pharmaceutical, biopharmaceutical, and medical device firms. Global Health Authorities have taken notice, and poor investigation activity is far and away the largest general theme of observations. This session will give you the foundation to establish robust Event Investigation activities in an efficient and compliant matter
FDA Guidance for Industry “Process Validation: General Principles & Practices” – Whatever Happened to IQ, OQ, PQ?0 Available
The FDA Guidance for Industry “Process Validation: General Principles & Practices” has been around since 2011, but few firms have fully grasped how FDA is aligning process validation activities with a product lifecycle concept. To integrate these approaches, the 2011 guidance emphasizes the collection and evaluation of data from the design stage through production, to prove your ability to consistently assure product quality. Even with this guidance, some companies still fixate on IQ/OQ/PQ and the “Rule of 3.” This session will help you align your process validation efforts with FDA other modern global guidance docs.
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.
Writing Effective 483 and Warning Letter Responses0 Available
The outcome of regulatory inspections is critical to an organization’s success. Though you do your best to avoid it, receiving a 483 or Warning Letter is inevitable. But ensuring that you are aware and understand what the regulatory agency is expecting in the response can be a challenge. What should you include? What are the risks of not submitting an appropriate response? This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.
Effective Batch Record Review – Getting It Right The First Time0 Available
Since a strong batch record review system is essential for the manufacture of pharmaceuticals, biologics, medical devices, etc., why leave anything up to chance? Fortunately, there are simple steps you can take to ensure your efforts are efficient and compliant. Join our interactive, 90-minute webinar where we will analyze each of the necessary elements of the batch record review process.