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Monique Mendoza Promoted To Head Of Quality At Pharmaceutics International Inc (Pii)


Hunt Valley, MD  Ms. Monique Mendoza has been promoted to Head of Quality for Pharmaceutics International, Inc. (Pii).
In her new, promoted role, Ms. Mendoza will be responsible for the entire Quality unit at Pii and report directly to the President and Chief Executive Officer, Dr. Kurt Nielsen. Her scope of responsibilities includes: Sterility Assurance, Batch Disposition, Investigations, Change Controls, Product Complaints, Supplier Qualification, Raw Material Release, Audits (internal, external and client), Document Control, and Quality Control across all facilities including Microbiology Laboratories.
“I am very excited about Monique’s new role and what it means to the future of our organization,” says Dr. Nielsen. “Monique is a gifted leader who has been instrumental in shaping Pii’s quality systems. Her dedication to continuous improvement and ensuring quality is the foundation of everything we do is second to none. In her new role, she immediately become ....

United States , Hunt Valley , Kurt Nielsen , Monique Mendoza , Pharmaceutics International Inc , University Of The Pacific , Pharmaceutics International , Chief Executive Officer , Sterility Assurance , Batch Disposition , Exchange Controls , Product Complaints , Supplier Qualification , Raw Material Release , Document Control , Quality Control , Dynavax Technologies , Bayer Healthcare , ஒன்றுபட்டது மாநிலங்களில் , வேட்டை பள்ளத்தாக்கு , கர்ட் நீல்சன் , மொநீக் மெண்டோசா , பல்கலைக்கழகம் ஆஃப் தி பெஸிஃபிக் , தலைமை நிர்வாகி அதிகாரி , தொகுதி மனநிலை , மாற்றம் கட்டுப்பாடுகள் ,

An Analysis Of MHRA's Latest Annual GMP Inspection Deficiencies Report


An Analysis Of MHRA s Latest Annual GMP Inspection Deficiencies Report
The U.K.’s Medicines and Healthcare products Regulatory Agency (
MHRA) has taken a different approach in the publication of the
GMP deficiencies for drug product issued during inspections in 2018 and 2019.  In 2015 and 2016, the MHRA provided approximately a 100-slide deck each year with tables, figures, and text from deficiencies against the requirements in the chapters and annexes. No data were formally published for 2017. The MHRA published a 6,200-plus line Excel spreadsheet of its 2018 GMP inspection data so that individuals could parse and present the data according to their needs. Last year we published analysis of the data in a two-part set of articles: “An Analysis Of MHRA s Annual GMP Inspection Deficiencies Report” and “The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter.” ....

Barbara Unger , Unger Consulting Inc , Regulatory Agency , Unger Consulting , Inspection Deficiencies , Quality System , Sterile Medicinal , Mutual Recognition Agreement , Outsourced Activities , Overall Deficiency Trend Comparison , Sterility Assurance , Computerized Systems , Qualified Person , Product Recall , Deficiencies Cited , Quality Risk Management , Quality Systems , பார்பரா அஂகர் , அஂகர் ஆலோசனை இன்க் , அஂகர் ஆலோசனை , தரம் அமைப்பு , மலட்டு மருத்துவ , ஒஉட்சௌூறசெட் நடவடிக்கைகள் , ஓவரால் குறைபாடு போக்கு ஒப்பீடு , கணினிமயமாக்கப்பட்டது அமைப்புகள் , தகுதி நபர் ,