Upcoming Live Courses
Critical Thinking In Clinical Research – A Better Wayhot
Attend this live webinar, to learn from recognized industry experts about the DIGR-ACT® Solution – an exciting methodology for supporting critical thinking in risks and issues management specifically designed for the clinical trial professional.
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control0 Available
Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance0 Available
Change control is a critical piece of any life sciences activity…and a global regulatory requirement. Change control deficiencies are mentioned directly or indirectly in most inspection observation findings. Compliance is a must, and a business imperative. This course will help you get on the right track with your change control programs, documentation, and overall compliance.
New FDA Draft Guidance – A Risk-Based Approach to Monitoring of Clinical Investigations0 Available
In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance. This new draft guidance is currently open for comment and further underscores FDA’s emphasis on clinical studies being overseen using risk-based techniques. This session will illuminate FDA’s thinking and help you prepare.
Building An Effective GMP Training System: A Risk-Based Approach0 Available
With the recent increase of job knowledge deficiencies being cited in regulatory inspections – especially in the areas of data integrity and sterile product manufacturing – training and qualification of personnel is becoming increasingly important to inspectors. Learn to define and understand the regulatory expectations around training and training systems in this webinar.
Developing a Part 11 Compliance Plan in Clinical Research0 Available
This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
Writing Effective 483 and Warning Letter Responses0 Available
The outcome of regulatory inspections is critical to an organization’s success. Though you do your best to avoid it, receiving a 483 or Warning Letter is inevitable. But ensuring that you are aware and understand what the regulatory agency is expecting in the response can be a challenge. What should you include? What are the risks of not submitting an appropriate response? This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.
Aseptic Processing: Preparing Staff and Programs For Compliance0 Available
Aseptic processing deficiencies are one of the most cited observations in FDA 483s and warning letters. Since regional regulatory bodies each have their own requirements, staying compliant can be a confusing and complex challenge.