Endotoxin Attributes, Detection, Clinical Relevance and BET – Interference Resolution – New Course
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This course discusses all aspects of the biological attributes, control, detection and risk management of bacterial endotoxin. Pharmacopeial methods and regulatory guides are discussed in detail with respect to microbiological control of endotoxin, design and validation of depyrogenation studies, creation of procedures for a robust bacterial endotoxin test (BET), and selection of BET methods, instrumentation and software. Management functions include preparation of the endotoxin sections of applications for new drugs or devices, and readiness for audits and inspections.
Agents and conditions that cause interference with the BET are detailed. Discussions include insight into the controversy regarding the role of lipopolysaccharide (LPS) and native endotoxin when conducting BET inhibition studies for in-process and finished parenterals. Experimental design for LPS and NOE recovery studies must address choice and activity of the analytes, incubation periods and BET methods. Case studies provide practical ways to overcoming BET interference conditions.
Participants are given practical examples for design of BET suitability studies, for calculation of alert and action limits for various drugs and devices, and for training and management of an efficient BET operation. The advantages of centralized laboratory versus sample point-of-use in a manufacturing environment are reviewed.
Who Should Attend
Those who work in biologics, small molecule, or vaccine manufacturing for testing, interpreting data, performing risk mitigations, or are involved in regulatory submissions for endotoxin measurement and investigations will benefit from this course.
- Quality Control/Quality Assurance - Technicians, Microbiologists, Managers and Supervisors
- Depyrogenation/Validation - Technicians, Specialists, Managers and Supervisors
- Water Systems - Specialists, Managers and Supervisors
Time: 8:30 a.m. - 4:00 p.m.
Agenda
Discover What's Happening Each Day
Upon completion of this course, you will be able to:
- Describe the chemical and physical characteristics of bacterial endotoxin
- Recognize the clinical relevant of endotoxin levels
- Identify the clinical symptoms of a pyrogenic reaction
- Discuss the principal sources of endotoxin contamination in a manufacturing setting
- Conduct a validation study for depyrogenation by dry-heat, washing or chemical methods
- Organize and direct a cGMP laboratory for robust bacterial endotoxin testing (BET)
- Write regulatory compliant procedures for endotoxin measurement
- Develop selection criteria for endotoxin detection methods and instrumentation/software
- Calculate product-specific endotoxin limits and set alert and action levels
- Conduct an endotoxin recovery study to distinguish low lipopolysaccharide or endotoxin recovery from other sources of BET inhibition
- Discuss sample preparation techniques for overcoming BET-test interference conditions
- Design a study to validate BET suitability tests for in-process and finished products
- Develop training and risk assessment programs for endotoxin control
- Investigate an endotoxin excursion and identify root causes
- Prepare endotoxin sections of regulatory submissions for new drug or device applications
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Hyatt Regency Crystal City at Reagan National Airport
2799 Jefferson David HwyArlington, VA
Beginning in 1970, Dr. Cooper pioneered development of the LAL test as a sensitive detector of endotoxin (pyrogen) in parenteral products. His publications span the history of LAL technology. In 1987, he founded Endosafe Inc., a producer of LAL reagent. He consults on endotoxin issues and is a retired Professor of Pharmaceutical Sciences at the Medical University of South Carolina College of Pharmacy, Charleston. He holds a Doctor of Pharmacy and a Bachelor of Sciences in Pharmacy from the University of Tennessee and a Master of Science from The Johns Hopkins University. He has held many offices in the American Pharmacy Association, Society of Nuclear Medicine, and Parenteral Drug Association, including the PDA Board of Directors (1983-85). He was presented the PDA's James P. Agalloco Award for Excellence in Education in 2013. He served on the USP Council of Experts for Sterile Compounding (2005-2010) for Chapter <797>.
Cheryl Platco, Principal Scientist, Analytical Sciences, Merck Research LaboratoriesMs. Platco has been involved with endotoxin testing for 28 years. She has experience with all three of the major U.S. LAL vendors (ENDOSAFE, LONZA and ACC.) She performs testing for pharmaceutical, vaccine, biological, and monoclonal products as well as a variety of raw materials, active ingredients, and culture media. Ms. Platco is involved with the PDA and BPOG Low Endotoxin Recovery task forces and has published numerous articles on the subject.
Registration
Pricing Options
More information coming soon.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #426 | ACPE #0116-0000-16-002-L04-P | 0.6 CEUs
Type of Activity: Application
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
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