SafeBridge Quarterly Newsletter
Trinity Consultants - SafeBridge
Scientific Solutions to Safety Problems
SafeBridge??Newsletter March 2023
In this Issue:
Upcoming Potent Compound Safety Training
Following are classroom trainings that will occur in the near future. Visit our?website?for a complete list of training.
New session added!
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.
Jun 27 - 29, 2023 --?Berlin, Germany
Oct 17 - 19, 2023 --?Raleigh, NC?-- NEW!
Who Should Attend?
?
New Staff in Toxicology
SafeBridge has recently added new staff with pharmaceutical, chemical, device and laboratory safety experience in toxicology and industrial hygiene.
Welcome to SafeBridge, Melinda Donnell, MPH!
Meet Melinda Donnell, MPH, our newest Senior Consultant at Trinity Consultants - SafeBridge? Regulatory & Life Sciences Group. She holds a Master of Public Health in Environmental Health Sciences & Policy from George Washington University, during which she evaluated the effects of titanium dioxide nanoparticles on oxidative stress in mice brain. She has over 5 years of experience in evaluating the toxicology, exposure, and potential risk to consumers associated with various chemicals in consumer products and foods as well as in occupational settings. She is both HACCP and PCQI certified.
Outside of work, Melinda enjoys gardening, traveling, and spending time with her husband Davis and son Wyatt.
Melinda [email protected]
To add this to your contacts,?click here.
Latest News
The SafeBridge? Regulatory and Life Sciences Group is proud to announce that its industrial hygiene analytical laboratory has successfully validated a surface method in support of USP <800> Hazardous Drug Sampling. SafeBridge's laboratory can now quantify up to 16 different hazardous drugs off one surface sample down to 5 ng/swab or 0.05 ng/cm2 based on 100 cm2 sampled. The hazardous drugs are:
SafeBridge will supply everything you need to sample and ship to our laboratory with our USP <800> Surface Sampling Kit. Each kit will include the following:
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SafeBridge's industrial hygiene laboratory is accredited by the American Industrial Hygiene Association - Lab Accreditation Program (AIHA-LAP) for the analysis of active pharmaceutical ingredients. The SafeBridge advantage is the application of the most sensitive techniques in the industry to detect potent drugs at very low concentrations in the workplace. The laboratory routinely develops methods and analyzes samples that contain biologically active pharmaceuticals such as steroid hormones, enzymes, peptide hormones, antibody drug conjugates (ADCs), and "cytotoxic" compounds. In addition, the laboratory conducts assessments of acceptable cleaning procedures to identify methods used to protect workers and to prevent product cross-contamination. The SafeBridge laboratory employs HPLC, LC/MS, and ELISA technologies to detect low concentrations of highly potent drug on filters and swabs.
The Modernization of Cosmetics Regulation Act of 2022
On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA), the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic Act (FDCA) and the passage of the Fair Packaging and Labeling Act (FPLA) in 1966. MoCRA requires:?
Additional provisions in MoCRA require the FDA to issue proposed and/or final rules on the establishment of good manufacturing practice (GMP) regulations, the establishment of standardized testing methods for detecting asbestos in talc-containing cosmetics, and the assessment of PFAS in cosmetic products and the scientific evidence regarding their safety.
Scientists at SafeBridge??Regulatory & Life Sciences Group can assist the cosmetic industry in complying with MoCRA’s requirements related to product safety substantiation, GMP regulations, adverse event reporting, recordkeeping, and labeling. For further assistance, please us at?[email protected].
Upcoming Conferences
Our experts will be exhibiting at the following conferences and we invite you and your colleagues to come by and see us. Our experts will be happy to answer any questions you have.
Philadelphia, PA
April 17 - 18, 2023
Philadelphia, PA
April 25 - 27, 2023
Washington, D.C.
May 17 - 18, 2023
Phoenix, AZ
May 22 - 24, 2023
Shanghai, China
Jun 19 - 21, 2023
June 20 - 22, 2023
Philadelphia, PA
Want to schedule a meeting with one of our team members? Contact us!
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Toxicology Board Certified; Regulatory Professional; Expert in Chemical Evaluation and Occupational Risk Assessment
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