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.
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.
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.
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.
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.
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.
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.
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
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.
