Upcoming Live Courses
Aseptic Process Validation: Top-Tips for Compliance and Success0 Available
If you manufacture sterile therapeutic products, then you know how critical Aseptic Process Validation is to ensuring compliance with mandates and guidance on a global scale. More importantly, you are aware of the impact on patient safety. This interactive session will cover what you need to know, and the best way to go about doing it. Lessons learned “from the trenches” and best practices gleaned from experience will be shared. Additionally, bonus handouts will be offered so you can immediately implement what you have learned.
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In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics.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
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.
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.
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.
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.