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.
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance0 Available
Change control is a critical piece of any life sciences activity…and a global regulatory requirement. Change control deficiencies are mentioned directly or indirectly in most inspection observation findings. Compliance is a must, and a business imperative. This course will help you get on the right track with your change control programs, documentation, and overall compliance.
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success0 Available
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best Practices(1)0 Available
Global regulatory agencies have the expectation that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA’s findings of deficiencies concerning equipment validation indicate they expect definitive evidence that the equipment meets mandated standards. This interactive session will highlight those standards and provide guidance for efficient, cost-effective qualification and validation programs.
Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings0 Available
Though billed as “The End of Validation as We Know it” when released in 2007, the ASTM E2500 standard didn’t quite revolutionize the validation process. Still, even with some limitations, it can be a useful guidance to help make your process more risk-based and efficient. This course will review several case studies that provide key lessons from implementing the E2500 approach over the past ten years.
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.
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.
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs0 Available
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.