MP-A Seminars

David will look at the difficulties being faced by manufacturers and auditors in conducting audits in the post pandemic world. Drawing on his extensive experience of auditing facilities around the world and virtually, he will look at how difficulties and challenges can be overcome to bring about a successful audit for both parties.

Aseptic isolators are commonly used in the pharmaceutical and life science industries in many applications, including filling lines, cell therapy processes, and sterility testing. This paper will outline some of the options and requirements that need to be considered when integrating an environmental or facility monitoring system (EMS or FMS) into these areas. It will discuss both viable and non-viable monitoring, and cover many of the aspects that need to be reviewed when producing a URS for such a system.

Presentation looks at exploring the benefits and requirements of holding a pharmaceutical wholesale licence, giving an overview of basic requirements to get set up and maintaining a wholesale licence alongside other business activities.

An overview of the regulatory requirements for training. GMP and GDP expectations with regards to training. How these requirements can be achieved in practice. Evaluation of an individual’s training needs – what they know already and what they need to be trained in. How to evaluate training and its effectiveness. Different learning styles and catering for these in training sessions.