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.
“Right to Try” laws allow terminally and severely ill patients to try medicines that have passed the first phase of the FDA/Health Authority approval process, but have not been fully approved for public use. This session will provide guidance on how to get your product to needy patients in a compliant, responsible, and safe manner.
As the gap between drug production and the patient shortens, strong Medical Affairs programs are more important than ever. This course will provide an overview of what great Medical Affairs organizations look like, their core activities, and the value they provide. This is the first session of our comprehensive nine-part certificate series.
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.
Quality risk management must now be a focus of any clinical quality system for all stakeholders, including investigative sites. Most sites have not incorporated the benefits of a risk-based approach to study conduct.
The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs. Current issues including cloud systems and data integrity will be discussed.
In this training, you’ll learn the five common areas where device trials tend to fail, plus review actionable steps to help you anticipate potential pitfalls and resolve them before they occur.
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