Blockchain Technology for the Life Sciences: A Comprehensive Primer0 Available
This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program0 Available
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.
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.
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients(2)0 Available
In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.
A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management0 Available
This GMP webinar will cover the design and implementation of a GMP surveillance program to ensure awareness of and compliance with ever-changing US and international GMP manufacturing regulations, guidance, inspection findings, trends, and related information, and how the process can be used to create GMP training and made even more valuable across the organization in the context of a quality knowledge management platform.
Aseptic Process Simulations – A Comprehensive Guide for Proper Execution0 Available
This course will help those using APS/media fills to determine their risks of contamination in the process and how they can prevent it. A complete review of what elements need to be included in the APS design will be discussed, which includes, frequency of performance, number of operators, what types of growth media to use, how slow or fast the filling line needs to operate and how to read the units after they have been incubated.
How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency0 Available
This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that manages the inspection process, or has input into CMO selection. This includes personnel in:
Other functions that may be subject to FDA and MHRA audits
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.