2023 Wrap Up - SafeBridge Newsletter
Trinity Consultants - SafeBridge
Scientific Solutions to Safety Problems
SafeBridge Newsletter
In this Issue:
Upcoming Training / Latest News / Expert Spotlight / Upcoming Conferences
Upcoming?Training
Following are classroom trainings that will occur in the near future. Visit our website for a complete list of trainings and on-demand webinars.
Featured Courses
Classroom Training
Feb 2 - 3, 2024 / Hyderabad, India
Feb 5 - 6, 2024 / Mumbai, India
This 2 day course in Pharmaceutical Potent Compound Safety, taught by the leading industry experts in potent compound safety, is designed for EHS and related professionals who need to understand the critical concepts of evaluating and safely handling pharmaceutical compounds.
The intensive curriculum focuses on evaluation of compound potency and toxicity, sampling and monitoring protocols, control technologies and application of qualitative and quantitative approaches.
The training offers NEW and improved content to help you with your potent compound safety issues and to train you on new aspects that have become important that were not in our course when we came to India in 2018, e.g., PDEs, ADCs, new modalities, and more on containment performance testing.
Feb 27 - 29, 2024 / San Diego, CA
Jun 18 - 20, 2024 / Cambridge, United Kingdom
This three-day course in pharmaceutical potent compound safety is designed for EHS and related professionals who need to understand the critical concepts of evaluating and safely handling pharmaceutical compounds. It is taught by the leading industry experts in potent compound safety, The intensive curriculum focuses on evaluation of compound potency and toxicity, sampling and monitoring protocols, control technologies, and effective investigation and communication approaches. After two days of introductory information, topics will shift to case studies and problem solving to address potent compound safety issues in discovery, development, contract manufacturing, and commercialization. It leverages a systematic approach to successfully support drug R&D and manufacturing operations.
Latest News
Hazardous Drugs in Health Care Settings – ARE YOU COMPLIANT with USP <797>/<800>?
SafeBridge and Working Buildings, both affiliated companies of Trinity Consultants, Inc. attended, presented, and discussed with pharmacists and health care staff at the American Society of Hospital Pharmacies (ASHP) Midyear Conference in Anaheim in December. At our mix and mingle event, we presented on the following topics.
Are you and/or your customers ready for your State Pharmacy Board audits of your facilities in the handling of hazardous drugs?
If not or you're unsure, use our combined resources that no other company has from design review of your facility, program review, compliance with the guideline assessment to wipe sampling, analysis and interpretation. The combined resources of SafeBridge and Trinity are the only technical resource consultant that can meet your entire USP <797>/<800> program compliance needs.
For more assistance and information, please contact [email protected].
SafeBridge Helps Clients Get Approvals for Their Drugs Requiring Complex Extractable and Leachable (E&L) Testing, Interpretation and Toxicological Assessment
For the second time in the past three years, SafeBridge has been able to assist Clients who have received FDA deficiencies and warnings about their regulatory submission package for dermal patch products overcome these challenges and get marketing approvals for their drug products Not only did we do the toxicological assessments which had been deficient due to improper evaluation of data and poor toxicological risk assessment approaches, e.g., not developing dermal Permitted Daily Exposure (PDE) values, but in our most recent case, helped design, place and interpret studies at laboratories for the E&L studies.
We also continue to support E&L submissions for parenteral and inhalation drug products and for devices to meet regulatory requirements, so we are doing many E&L assessments per year from design of studies to regulatory submissions.
SafeBridge and our subcontractor, Material Needs Consulting, provide the following services in E&L for biotechnology and pharmaceutical product development including the following:
For more information, please contact: Mac Taylor, DVM, DABT at [email protected] or [email protected].
领英推荐
GRAS isn’t just for Livestock!
In the Food & Beverage world, GRAS is not just something to feed to cows. GRAS is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered to be ‘generally recognized as safe’ (GRAS) by experts under the conditions of its intended use. Experts in the SafeBridge Tox-Reg group have achieved very high success rates in obtaining GRAS status for food and beverage ingredients. The FDA-GRAS process can be challenging, as the supporting dossier must adequately describe and justify that the new ingredient is safe via a thorough narrative encompassing the substance’s identity and composition, manufacturing process, and summaries of toxicological and human studies related to the safety of the substance for the intended use. An important consideration is assessment of any potential allergenicity of the ingredient. Estimating exposure is a key determining step in the evaluation of a food substance, as the safety is related to total cumulative intake, i.e., proposed new uses plus background dietary exposure. SafeBridge coordinates GRAS panels, a group of experts responsible for evaluating the dossier. If the GRAS panel determines that there is a consensus within the scientific community that the substance is safe for its intended use in food, is manufactured according to current Good Manufacturing Practices (cGMP), and meets appropriate food specifications, the substance may be granted GRAS status. From there, our Clients may decide to submit the GRAS Dossier to the FDA (GRAS Notification) or decide to maintain a Self-Affirmed GRAS.
GRAS is the core of our Food & Beverage offerings – from facilitating the approval for our clients, performing dietary exposure assessments, or serving as experts on GRAS panels coordinated by other consultants. Let us show you our passion for developing client relationships to bring forth meaningful change.
More Articles
Expert Spotlight
Matthew Linman
Meet our newest Senior Consultant, Matthew Linman, Ph.D.! Previously, Matt was the Assistant Scientific Director for the Flavor and Extract Manufacturers Association of the United States (FEMA) where he was responsible for managing scientific work focused on flavor safety, the FEMA GRAS (Generally Recognized as Safe) program, the FEMA Science Affairs Committee, scientific manuscripts, and exposure assessments. Before joining FEMA, Matt worked as an engineering scientist at Meso Scale Diagnostics (MSD) developing new instruments along with associated consumables and assays for the next generation of electrochemiluminescence (ECL)-based products. Matt received his B.A. in Chemistry from The College of Wooster and Ph.D. in Analytical Chemistry from the University of California at Riverside where he developed biointerfaces and novel materials for biosensing applications using surface plasmon resonance spectroscopy (SPR) and SPR imaging.
Matt is an avid distance runner (ran cross-country/track in college) and a decent ballroom/Latin dancer. He enjoys spending time with his physicist wife, Kathy, and his daughter, exploring all that the Washington, DC area has to offer. Connect with Matt Linman.
Deirdre Love
Meet Deirdre Love, PhD, MPH, CPH,?one of our Associate Toxicologists!
Deirdre’s passion for science began as an undergraduate at the University of South Carolina, where she earned a bachelor's degree in Public Health. Following graduation, she joined the master's in public health program at the University of Florida. While a master's student, she worked for the USDA on a Department of Defense project to protect deployed soldiers from vector-borne infectious diseases. She then went on to join the PhD program where she focused on aquatic and human health following exposure to pesticides.
In her free time Deirdre enjoys reading, travelling, playing tennis, and being out on the water with her husband.
Connect with Deirdre Love.
Dylan James
Meet Dylan James, our newest Associate Industrial Hygienist!
Dylan is a recent graduate of the University of North Carolina and SafeBridge's most recent TAK Scholarship recipient. Dylan is currently completing his master’s at the Gillings School of Global Public Health in environmental sciences and engineering with a focus on industrial hygiene.
Dylan is passionate about protecting the health of workers. Before starting with SafeBridge, he gained experience in industrial hygiene by interning with Liberty Mutual and Fujifilm Diosynth Biotechnologies. He also spent his undergrad working as a part time industrial ventilation consultant for Air Systems Corporations and is currently an instructor at the North Carolina Industrial Ventilation Conference.
Dylan loves being outside. He regularly enjoys taking trips with friends outdoors to rock climb, ski and mountain bike.
Connect with Dylan James.
Upcoming Conferences
Jan 22 - 24, 2024 / Pentagon City, VA
Anne Chappelle will be attending. Presentations by Bob Sussman and George (Mac) Taylor.
Feb 27 - 29, 2024 / Boston, MA
Lillian Fry, Allan Ader and others will be there! Visit us at?our booth.
Mar 6 - 8, 2024 / Raleigh, NC
Amy Snow will be presenting SafeBridge. Don’t forget to stop by our booth!
Mar 10 - 14, 2024 / Salt Lake City, UT
Stop by Booth #1305?and say hello to the?SafeBridge Tox?team!
Amazing content as always, #SafeBridge team! ?? As Steve Jobs once said, "Innovation distinguishes between a leader and a follower." Your dedication to #healthandsafety and #training in the pharma industry clearly sets you apart as leaders. Keep up the brilliant work! ???? #inspirationalquotes
Toxicology Board Certified; Regulatory Professional; Expert in Chemical Evaluation and Occupational Risk Assessment
1 年Our last newsletter of the year!