About this course
This full day workshop will be invaluable to those individuals involved in laboratory operations supporting pharmaceutical R&D and commercial operations. It will also provide useful information for those individuals already familiar and skilled in the GxP environment but seeking refresher training and input on current industry trends and issues in laboratory operations.
Morning 08:30 – 12:00
- Laboratory GMP Requirements
If you only wish to book the morning session on-line follow this link
Afternoon 13:00 – 16:30
- Investigating Out of Specification Results
If you only wish to book the afternoon session on-line follow this link
If you wish to book both sessions follow the ‘Book Now’ link on the right
Course outline
Morning 08:30 – 12:00
Laboratory GMP Requirements
This short course will provide an overview of GMP expectations of the pharmaceutical laboratory, focusing on common areas of concern for GxP laboratories, and common areas of weakness cited by regulators.
It will cover topics related to data and document management, personnel and training and instrument qualification including the following topics:
- What data is required to be maintained to support analytical results?
- How do you store the data?
- What level of review of data is required?
- Laboratory notebooks vs. worksheets vs. LIMS/ELN
- Importance of test methods within the commercial, pre-commercial or clinical laboratories
- Why is the laboratory training program important and how do you set up an effective program?
- Why do you need qualified instruments and is calibration sufficient?
Differences between laboratories supporting clinical operations vs. commercial operations are highlighted. Your instructor will provide insight to best practices for laboratory operations.
Afternoon 13:00 – 16:30
Investigating Out of Specification Results
The management of Out of Specification (OOS) results is a critical aspect of laboratory operations. Frequently, OOS procedures are difficult to follow, leading to skipped steps and data gaps. This course will review best practices to assure OOS systems result in excellent laboratory investigations that are fully compliant with regulatory expectations and system weaknesses frequently encountered. The history and background of current OOS guidelines will be covered by our instructor.
Continuing Education Credit: ACPE Continuing Education Units = tbc
Reference Activity Number = tbc
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
NSF-DBA Boston Office
These courses will take place in NSF-DBA own training facilities
NSF-DBA USA LLC
Training Facility 6th floor
129 South St
Boston MA 02111
For Travel Directions To Our Offices From South Station Please Follow This Link
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for these workshops is:
What you've said
“Before this class I only had minimum knowledge of this subject. I have learned so much from this course that will assist me in my career”
Gerard Amado, Drug Development Resources, MA, USA
“Very good information on the regulations that I can use in my day-to-day work”
Deborah Sutliff, ImmunoGen Inc., MA, USA
An NSF International Company 
