2021 PDA/FDA Joint Regulatory Conference
September 27 – 29, 2021 (Monday – Wednesday)
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Greenleaf Health, Inc.
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Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.
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Amgen
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Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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Pharma Manufacturing
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Each issue of Pharmaceutical Manufacturing magazine reaches more than 25,000 operations and engineering professionals in the pharmaceutical and biotech industries. Our readers are responsible for ensuring the safe design, construction, and operation of one of the most highly regulated industries in the world. These decision makers turn to Pharmaceutical Manufacturing for help in interpreting the ever-changing landscape of government regulations and to discover new technologies and best practices that will help them improve process efficiencies while ensuring uncompromised product quality.
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INTERPHEX
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Gain direct access to the largest volume of quality pharmaceutical and biotech decision-makers seeking to explore and source products, services, and turnkey solutions across the entire product development lifecycle – drug development through commercialization.
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Veltek Associates, Inc.
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VAI’s manufacturing and testing operations mirror current GMP/GLP standards. With more than 35 years of contamination control experience, our products and services include a comprehensive line of disinfectants, sporicides, residue removers, process cleaners, quality water, saturated and dry wipes, disposable garments, cleanroom paper, documentation materials, RFID tracking systems, printing systems, viable monitoring, particle counting, cleanroom cart systems, cleaning equipment, consulting, and laboratory services.
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SQA Services, Inc
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SQA provides outsourced supplier management programs for quality-critical industries, including fully-managed programs for audits, assessments, engineering, source inspection, corrective action management, and remediation. SQA develops, implements, and executes supplier quality solutions that complement and extend client quality teams to secure and improve the global supply chain.
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Pharmaceutical Technology
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Pharmaceutical Technology offers news, analysis, and peer reviewed research in formulation development (including excipients) and drug manufacturing to more than 38,000 decision makers in the top pharmaceutical, specialty pharmaceutical, and biotechnology companies via the Pharmaceutical Technology print magazine, PharmTech.com, and three newsletters: ePT, Sourcing and Management, and the Equipment and Processing Report.
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PQE US Inc.
Founded in 1998, PQE Group is a consulting company in the pharmaceutical field that has its Headquarter in Reggello (Florence, Italy) and since 2012 has opened 26 offices worldwide, developing a network of contacts at international level. Certified ISO 9001 since March 2003, PQE has been characterized as Complete Quality Solutions Provider for companies operating in the Life Science field, both nationally and internationally. It currently has more than 900 employees distributed in the operational offices in Italy, Germany, Spain, France, Switzerland, UK, Belgium, Poland, Russia, Israel, USA, Mexico, Brazil, Argentina, India, China and Japan.
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ValGenesis, Inc.
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ValGenesis, Inc. is the creator of the VLMS, a SaaS platform that serves as a foundation for managing compliance-based validation activities in life science companies, fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
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Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of more than 10,500 members worldwide.
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Avatour
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Avatour is the remote collaboration platform that uses 360° capture technology to immerse users in a location as if they were actually there. Through a standard web browser or optional VR headset, users can connect people with places, interact with their environment, and record sessions for later review. By removing distance as a barrier, Avatour helps professionals get the job done without travel, providing an opportunity to reimagine their existing operations.
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