Ready to join a live, 90-minute webinar with some of the industry’s leading experts?
LSTI’s live webinars connect you with subject matter experts who bring real life examples to their courses.
Our GCP, GMP and GLP training brings the most current information straight to your desk. Connect with the latest FDA training and see how regulatory authorities affect the pharmaceutical, medical device and life science industries.
Discover best practices in clinical trials and how to best establish a compliant program.
Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.
Browse our upcoming live webinars below.
Clinical Quality Management Systems (QMS): Establishing a Practical & Compliant Program
Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity. However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities. Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety. This course will give you the necessary tools to establish a working and compliant QMS for your business.
FDA REMS Inspection Guide: Audit Preparedness Best Practices
Following the April 2018 implementation of the FDA compliance program document describing their Risk Evaluation and Mitigation Strategy (REMS) Inspection program, they have been ramping up focus on REMS inspections. If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard.
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.
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
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.
Best Practices for Deviation Investigations: Cost-Effective Problem Correction0 Available
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan (CAPA). Learn how to identify and classify deviations for easier management and investigation.
Change Management Plan Development for Risk-Based Clinical Studies: From Site Monitoring to Vendor Management and Beyond0 Available
With the recent ICH E6 changes to include Quality Management in the conduct of clinical trials, it is important for companies to understand how to implement Quality Management – which includes Risk-Based Monitoring (RBM) – into their studies. The purpose of this session is to help you develop and implement a change management strategy that eases the burden of transition.