About this course
This full day workshop will be invaluable to those individuals new to 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 want to book the morning session on-line follow this link
Afternoon 13:00 – 16:30
- Investigating Out of Specification Results
If you only want to book the afternoon session on-line follow this link
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 share experiences with global laboratory management and PAT applications.
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 and system weaknesses frequently encountered. The history and background of current OOS guidelines will be covered by your instructor.
Continuing Education Credit: ACPE Continuing Education Units = 0.3 CEUs per session
Reference Activity Number 0616-0000-11-005-L04-P
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
Royal Sonesta Hotel Boston, MA, USA
The Royal Sonesta hotel is minutes from downtown Boston. Located
along the Charles River, it is close to many of the Boston historic sites,
including the Boston Science Museum. There is excellent shopping
nearby.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the Royal Sonesta
Hotel. A limited number of rooms are available at this rate. Hotel
reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement
is the delegate’s responsibility.
There are a number of other hotels located within minutes from the
Royal Sonesta Hotel including the Marriott Hotel, the Courtyard Inn
and Le Meridien Hotel, all situated in Cambridge. Downtown Boston
hotels are within 15 minutes by taxi or public transportation of the meeting venue.
Royal Sonesta Hotel, 40 Edwin Land Blvd., Cambridge, MA 02142, Tel: 617-806-4200.
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 experts for this course are:
Dr Glenys Foster Roberts, PhD
Glenys is an Analytical Chemist with senior QC experience on a global scale and with generics industry background. She was the VP of Global QC at Barr until its acquisition by Teva. Glenys has extensive experience managing large scale QC laboratories, with a focus on compliance combined with effectiveness. Recent project work includes leading PAT initiatives and she has authored papers on the topics of PAT as it applies to the generics industry.
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
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