Contamination In-Vitro Manufacturing 
Pharmaceutical Technology
JANUARY 6, 2023
The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplicity matters. Optimising development and scale-up.
pharmaphorum
AUGUST 24, 2020
The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.
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The Pharma Data
MAY 3, 2021
Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .
XTalks
OCTOBER 8, 2024
The approval was awarded to Abbott’s Alinity m MPXV assay, the first mpox in vitro diagnostic (IVD) listed under the WHO’s Emergency Use Listing (EUL) procedure. It is intended for use by trained clinical laboratory professionals skilled in PCR techniques and IVD procedures. Mpox has led to at least 635 deaths in the DRC this year.
Camargo
NOVEMBER 29, 2021
They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations). Small molecules have known structures and are primarily chemically synthesized. ADME and Dosing Regimen.
Cloudbyz
AUGUST 19, 2024
Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. What is the Medical Device Safety process?
pharmaphorum
AUGUST 4, 2022
If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.
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