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.
A Risk-based Study Management Approach for Clinical Trial Sites0 Available
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.
Auditing Validated Computer Systems In A GxP Environment0 Available
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.
CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum0 Available
Do you have a system in place to prevent noncompliance and to ensure effective action planning with follow-up in the event of a significant deviation? The ICH E6 GCP updates expects that you do!
Attend our webinar training on the essentials of CAPA and Root Cause Analysis to apply to your clinical trials!
Clinical Regulatory Document Management Compliance Professional (CRDMCP)
Successful completion of these three training sessions is intended to meet the needs of individuals who are either new to biopharmaceutical-based document management, Information Management, and regulatory submission publishing for health authorities, or already experienced in one area and looking to gain a broader understanding of the full continuum of regulated document and submission production activities.
Cloud Computing In A GxP Environment: Three Key Success Factors0 Available
The focus of this training is to understand how to transform traditional vendor and infrastructure qualification activities and software validation activities into actionable steps for ensuring compliance in the cloud, whether it be with IaaS, Paas, or Saas approach.
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions0 Available
While pharmaceutical and biotech companies outsource clinical trial tasks to CROs, Sponsors retain responsibility for the safety of subjects and regulatory requirement compliance and must ensure that the CRO is managing the trial correctly. Join our 90-minute interactive to identify the steps of conducting an effective audit to determine a CRO’s compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.
Conducting the CRO Pre-qualification Audit for GCP Compliance – Key Risk Factors to Avoid0 Available
Far too often, companies select and contract with a Contract Research Organization (CRO) without conducting a “due diligence” audit for GCP compliance. Even when sponsor firms do audit potential CRO partners, the review is often substandard or misses key GCP qualification points, ultimately putting deliverables, data, and other critical activities at risk.