Live and On-Demand Training - Life Science Training Institute

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A new ICH E6 Good Clinical Practice (GCP) revision linked to the revised ICH E8 (R1) Guideline “General Considerations for Clinical Trials” is due to be finalized soon. These changes are coming during (or soon after) the COVID-19 pandemic which hugely tested GCP systems, revealing that many are not well equipped to adapt to risk. Join us for this 60 minute session where you will learn where these guidances are headed…and what you can do immediately to prepare.

$279.00

Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA Guidance

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This webinar presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.

$279.00

Regulatory Affairs in China – The New Drug Regulatory Framework

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This session will introduce the official institutions governing drug development and registration in China and a detailed overview of the requirements laid out in the revised DAL and new DRR for the development of pharmaceutical products.

$279.00

Effective Writing for Investigation Authors and Reviewers

Monica Guzman

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If you are working in a regulated life sciences environment and required to write, edit, or review your organizations’ investigation reports, this is the webinar for you. Learn strategies for improved efficiency and effectiveness in your writing process, helping you to write reports that are more readable, easier to follow, and in line with auditor expectations.

Pharmaceutical Sampling Plans – Understanding for Compliance

Mark Allen Durivage

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The use of acceptance sampling is common in the life science industries. Understanding sampling plans and their linkage to risk is a key to compliance. This course will provide you with how to maximize the effectiveness of your sampling plans to mitigate risk and ensure compliance.

Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 Restrictions

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This course discusses the need for quality documentation of events that occurred during the crisis that are linked to significant risks and issues that matter. You will review important actions and documentation between various stakeholders (read: sites and sponsors, CROs and sponsors, etc.) which must happen to ensure deviation identification, root cause analysis (RCA), and Corrective and Preventative Actions (CAPA) are handled in a compliant fashion.

$199.00

Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 Pandemic

Michael Pierro

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Most pharmaceutical and biotech companies (sponsors) outsource the management and conduct of their clinical trials to a Contract Research Organization (CRO). Although sponsors can delegate tasks to a CRO, they continue to be responsible for subjects’ safety and overall trial compliance to regulatory requirements. This is a difficult task under normal circumstances, but seemingly impossible under current COVID-19 travel restrictions. Even with this challenge, global health authorities will still expect sponsors to have complete and uninterrupted oversight of their CRO partners.

Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

Mark Allen Durivage

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Good Manufacturing Practice (GMP) audits can be difficult under normal circumstances, but especially under mandated quarantine periods like the current COVID-19 crisis. Remote audits allow an organization a viable alternative to ensure continued compliance with GMP by leveraging modern technologies and best practices. This course will show you how to stay compliant while fulfilling audit responsibilities remotely.

Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions