Pharma / BiotechMedical Device
This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments and validation of relevant methodologies.
The course also covers in detail issues involving the roles and responsibilities of the Study Director in planning, supervising and managing pre-clinical studies. Also, the analysis and reporting of study results will be discussed. Also included is a discussion of functions related to quality assurance unit responsibilities and the need to effectively audit laboratory activities and data for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance including those required at collaborator sites, records management, GLP special requirements, archiving of data and inspections.
The roles and responsibilities of Quality Assurance in the control of daily activities, data collection, analysis and archiving of study information will be discussed. The roles of the Study Director and QA in regulatory and client inspections will also be presented.
The course also discusses how to manage regulatory inspections, and how to respond to regulatory findings and audits. Inspection results for sponsoring companies and CROs are included in these discussions.
Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. Many Bioanalytical laboratories have also chosen to follow GLP as the quality system for the control of testing for pharmacokinetic and other clinical studies. This ensures the consistency and reliability of results for submissions to the USFDA, USEPA, the OECD and other national organizations.
This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this course.
This course is also useful for quality assurance and quality control managers, coordinators of multi-site projects, regulatory affairs professionals, auditors, and senior management interested in effective QA techniques. New and experienced staff from the food, pharmaceutical, medical device, nutraceutical, agrochemical and cosmetics industries will learn the fundamental principles and applications of GLP, particularly in the complex multi-site environments of today’s industry. The course will also benefit professionals from CROs that operate under the GLPs.
Section 1: Introduction: The GLPs
Section 2: The Regulations – 21 CFR 58
Section 3: It Starts at the Top – Organization, Management & Documentation
Section 4: Implementing GLPs:
Section 5: Study Director
Section 6: Quality Assurance
Section 7: Regulatory Inspections
Section 8:GLP Inspection Observations (Workshop)
Section 9:Emerging Issues
By the end of this three-day course, attendees will have a strong understanding of the fundamental compliance requirements for current Good Laboratory Practices, and will be able to apply compliance protocols in all efforts aimed at generating regulated data for evaluation by the US FDA, USEPA and regulatory agencies overseas. All participants will gain a fundamental understanding of the basis of the regulations and the necessity of rigorous implementation. Special attention will be given to incorporating proactive thinking and a robust compliance regimen in all scientific matters. The consequences of non-compliance will be examined, including a thorough review of examples of previous FDA inspectional findings.
"We have had extensive training in the webinar setting, but this was much more comprehensive as a course setting. The information was presented in a very clear and detailed manner, in line with other information we have pulled in from consultants." Dr. Jaime L., Associate Manager, Regulatory Services, GENEWIZ
"The Course Director is an excellent instructor and I really liked that he was willing to engage in so much discussion and question/answers." Jana M., Quality Consultant, McCulloch Quality Consulting LLC
"I really enjoyed the class. It was easy to interact and ask questions. The materials (binder, etc.) provided are great! They will be a wonderful reference for our lab." Melissa R., Research Asst. III, Wyss Institute
"The Course Director brought a new perspective to training which I have received (repeatedly) over my 26 years in the small molecule pharma industry – the discussion was fresh! The most interesting GLP training I have attended in years." Susan L., Quality Control Scientist, Incyte
"Very well done. The fact that the course director is an experienced scientist made a big difference." Stephen T., CEO, Protea Biosciences
"The course material was very informative and obviously reflected current industry thinking and practices. The instructor was also able to share and discuss real-life situations." Christine C., Deputy Director, RD/QA
"Overall, I was impressed by the entire package, and I found the course of great utility." Matthew P., Director, R&D, Protea Biosciences
"I really enjoyed the extensive information in this course. I highly recommend it to anyone in the scientific industry. It has been a great experience." Cecilia S., Scientific Associate II/, Qiagen Sciences
"The course director made the course very informative with real life anecdotes. This was a great class!" Deepa D., Lab Operations Specialist, Canon US Life Sciences
"The course director did a great job. He was complete in his explanations and was able to keep our attention. Very informative." Brooke H., Research Scientist, Celsense, Inc.
They are similar in many ways, especially in the area of documentation. However, GLPs focus on the reliability of data that is generated during the development of potential products during research studies, while GMPs focus on the reproducibility of products, either near the end of the research effort or after the product has been approved for marketing.
No! The GLP Regulations clearly state that Quality Assurance must be independent from the Study Director. Since the Study Director supervises the technical performance of the study, the Auditor cannot be part of the study group. A government inspector always checks to be certain that QA is independent from the study group.
No, they do not. An inspector can ask to see audit findings, but audit reports do not have to be presented. A Sponsor must show proof that studies, facilities and data were audited at appropriate intervals, but actual findings can be withheld.
In this video, both an attendee and Kay Monroe, a pharmaceutical industry veteran and the instructor of our “Effective Document Management Systems” course, discuss the benefits of our approach to training courses.
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