Upcoming Live Courses
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.
cGMP Compliance – Understanding The Top Drug Enforcement Trends0 Available
Compliance with Good Manufacturing Practices (GMP) is a constant source of energy, cost, and stress for pharmaceutical and biopharmaceutical manufacturers, and staying abreast of ever-changing regulations can be a struggle. Plus, as regulators are sharing information and harmonizing approaches, existing data suggests common areas of issues being found by multiple inspectorates.
Establishing Appropriate Quality Metrics0 Available
In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics. New compliance and inspection policies could be developed as a result of submitted quality metrics. Establishing quality metrics now will help your company prepare for any future regulations as well as drive your Quality Culture toward continuous improvement.
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
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 110 Available
As technology improves, clinical trials are increasingly becoming more “digital.” Compliance therefore becomes more complex and evolves quickly. Everything from patient safety to consumer confidence is at stake. This course will show you how to bring electronic signatures in compliance with FDA 21 CFR Part 11 requirements for electronic records.
Best Practices in CMC Dossier Preparation – Facing Tough Challenges0 Available
Managing the construction of a clear, concise dossier can be a daunting task, but it doesn’t have to be. A simple understanding of best practices surrounding the creation and presentation of the CMC section will make for a successful submission…as long as your data is accurate and compelling!
Cleaning Validation – Lessons Learned in the Trenches0 Available
seatsCleaning Validation is a regulatory requirement that global health authorities take VERY seriously. Many observations and warning letters either directly or indirectly cite deficient cleaning protocols. In short, why endure the risks if you don’t have to? This course will focus on three major areas of deficiency across many cleaning validation programs: determining carryover acceptance criteria, developing cleaning processes and periodic evaluation of validated cleaning processes.
Clinical Finance: Key Strategies to Stay in Control of Your Study Budget0 Available
Whether you are kicking off a new project, trying to regain control of ongoing study financials, or just trying to gain best practices, this session will help reduce unpredictable scope increases and “wow” change orders, keeping you on top of your budget through your trial.