Regulatory & Compliance
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum
The recent update to ICH GCP E6 (R2) emphasizes the use of “smarter” onsite, remote and centralized monitoring practices. Join our interactive live webinar to receive a practical guide to implementing an effective monitoring plan.
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum
Investigator Oversight is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
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!
ICH E6 Addendum R2 Team Training and Action Planning
The new revision of ICH E6 Guidelines (R2 Addendum) focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation. Join our webinar to learn about the major updates to train your team and be ready to implement the guidelines.
CRO Oversight Post ICH GCP E6 (R2) Addendum
With the release of ICH E6 R2 GCP update, risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Join us for this 60- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan.
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum
Good Documentation Practices are essential to a clinical trial’s success. New ICH GCP E6 (R2) guidelines provide updates and clarity to GCP definitions for documentation. Join us for this interactive session to learn more.
How To Establish The Number of Runs Required For Process Validation0 Available
During process validation, setting your “number of runs” is critical to establishing defensible efforts in the eyes of regulators. This session will give you the tools to tailor that number, plus provide best practices. You will also receive helpful job aids for use long into the future.
Quality Risk Management Post ICH GCP E6 R2 Addendum
Quality Risk Management (QRM) is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach0 Available
Environmental Monitoring (EM) is a critical component to ensuring microbial contamination control in pharmaceutical product development, research, and manufacturing settings. Using a risk-based approach to EM can save money while improving efficiencies and product quality. This webinar will show you how.