62938 Courses

Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this short course we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.

Life is full of learning and as unschoolers your children are learning through their own lives. But now it comes to conversations with your Local Authority and their need to be assured that your child is in receipt of a suitable education, how do you translate your child's day to day activities into an educational report?

Prevention of contamination is one of the most important goals of GMP. Contamination of product is often difficult to detect, so GMP rules emphasise preventive measures, including: attention to personal health and hygiene, and the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. In this short course we set out the basics of GMP requirements in these vital areas.

Analytical statistical elements are essential concepts in the design of clinical trials. This analysis helps us to understand whether a conclusion from a study of a sample of the target population applies generally to that population as a whole. In particular, it helps us to answer the question: Did the treatment effect in the given study occur just by chance? The statistical elements of a well-controlled study minimise the chances of drawing the wrong conclusions, by providing clear thresholds for such errors. The basic statistical elements of a clinical trial include eligibility criteria, randomisation, sample size, power, and blinding, and these are discussed in this short course.

The sponsor of a clinical trial takes responsibility for its initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organisation, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Duties and functions discussed in this short course include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports. ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.

Reporting to the LA when your child is in burnout

Unschooling PDA children