Are you new to GLPs or what to learn more about what the excitement is all about? This introductory webinar is essential to learning the basics. We will explain the purpose of the GLPs, give some background, and then also describe objectives and key elements of GLPs. FDA, EPA and OECD GLPs will be discussed.

This is for people who have not taken a GLP training class previously, and who want to gain some background information on what the GLPs are all about. Participants who want more in-depth GLP learning will want to register for the 2-hour session GLP Training 101 sessions.

This is a very short (2-hour) and basic GLP course, but in more detail than the Introduction to GLPs course. We will describe some detail of key elements of the GLPs and give some examples of regulatory citations, including FDA 483s. FDA, EPA and OECD GLPs will be discussed.

How did the GLPs come about? Why do we have to have our labs and labwork regulated? Consumer safety is of utmost importance to governmental agencies. This webinar will illustrate the history of the Good Laboratory Practices.

The GLPs were not originally written with the analytical/bioanalytical laboratory in mind. However, Sponsors and Study Directors are now insisting that these types of studies be conducted according to GLPs. Learn how GLPs can be integrated in the analytical and bioanalytical laboratories. Similar situations are found in the clinical pathology and forensic laboratories. The course also focuses on equipment and method validation.

This webinar will present information on SOPs for use in GLP environments, including what they are for, what to include, what not to include, how to prepare SOPs, and who should prepare the SOPs. It will also cover how to approve, distribute, maintain and update the Standard Operating Procedures. We will suggest what to do when personnel will not follow their SOPs, and what to do when a protocol conflicts with an SOP.

Many GLP studies or portions of GLP studies need to be outsourced to CROs.  There are numerous systems and resources that need to be checked to help ensure that the CRO in question is conducting activities as per the GLPs.

The quality and integrity of the data is the ultimate responsibility of the Sponsor, and the Sponsor’s Quality Assurance Unit is one function that performs outside audits. Another group that may perform audits is the third party auditor, or a consultant.  This course will assist the auditor in learning what to look for when auditing a study or a facility. Special attention will be paid to personnel, equipment, test article, protocol and reports, and the archive.

Learn how your University laboratory can use GLP methods to your advantage. Universities have a disadvantage in that there is high turnover of personnel assigned to studies, and the reporting system is not optimal for GLP organizational charts. In addition, universities often share equipment between labs and non-GLP studies. We will sift through the confusion with regard to these points and terminology, e.g., PI, and suggest assignments to roles, e.g., Test Facility Management.

Too often, the Sponsor has no idea that they are legally responsible for the GLP-quality of their Regulatory Submissions. The GLPs specifically state that Sponsors have regulatory responsibilities. They must have the education, training and experience to do their many job functions. Sponsors should to be aware of what is required of them before they even start a GLP program.

With SEND as a regulation for FDA submissions starting in 2016, Sponsors also need to know how to prepare for this data system, and cannot rely on their CROs to coordinate data files from ALL of the CROs involved in their GLP Programs. Knowledge of the regulations is essential; therefore, Sponsors must be trained on GLPs.

Test Facility Management has many duties. Knowledge of the GLPs is essential, as even Test Facility Management must be trained on GLPs. This informative webinar will focus on the Test Facility Management and GLP requirements, experiences and examples typical of what Management may encounter in a GLP situation. We will also give examples of FDA 483s that were issued based on Test Facility Management citations.

In this GLP training course, we will cover more details than the Basic GLP Training 101 course. We will describe some detail of key elements of the FDA GLPs (21cfr Part 58), and discuss some FDA 483s. Roles and responsibilities of key personnel will be discussed. This course is targeted for personnel who need to learn about Good Laboratory Practices for job activities, or those who are interested in learning more to help make their laboratory GLP compliant.

The agenda includes:

• Scope and definitions
• Personnel
• Animal care
• Facilities
• Equipment
• Standard Operating Procedures (SOPs)
• Test and Control Article
• Protocol and reporting of GLP studies
• Documentation
• Study conduct
• Storage of records
• Multisite studies

The Study Director is the single point of control in a GLP study, and has many duties. This informative webinar will cover items in the GLP Training 201 Webinar, but focus on the Study Director and GLP requirements, experiences and examples typical of what a Study Director may encounter in a GLP situation. We will also describe deviations and amendments and how the Study Director’s involvement with these issues is critical to the study. Examples of FDA 483s related to the Study Director will be presented.

This course is for those who need to learn more about the Study Director’s responsibilities.

In this GLP training course, we will cover more details than the Basic GLP Training 101 course. We will describe some detail of key elements of the EPA GLPs (40CFR Part 160), and discuss some Inspection Findings. Roles and responsibilities of key personnel will be discussed. This course is targeted for personnel who need to learn about Good Laboratory Practices for job activities, or those who are interested in learning more to help make their laboratory GLP compliant.

The agenda includes:

• Scope and definitions
• Personnel
• Animal care
• Facilities
• Equipment
• Standard Operating Procedures (SOPs)
• Test and Control Article
• Protocol and reporting of GLP studies
• Documentation
• Study conduct
• Storage of records
• Multisite studies

The Study Director is the single point of control in a GLP study, and has many duties. This informative webinar will cover items in the GLP Training 201 Webinar, but focus on the Study Director and GLP requirements, experiences and examples typical of what a Study Director may encounter in a GLP situation. We will also describe deviations and amendments and how the Study Director’s involvement with these issues is critical to the study. Examples of relevant Inspection Findings will be presented.

This course is for those who need to learn more about the Study Director’s responsibilities.