Author Archive for: mgatta@icqconsultants.com
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Principles of Quality-by-Design in Pharmaceutical Development
The Key Concept: The Quality-by-Design (QbD) concept is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management [ICH Q8 (R2)]. A key assertion of QbD is that quality is controlled not by simply testing the product, but […]
ICQ will be attending the American Pharma Outsourcing Summit 2018 at the Crown Plaza Hotel, Cherry Hill, NJ
The American Pharmaceutical Outsourcing Summit is designed to provide pharma outsourcing executives with current trends, strategic insights and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operation excellence, supply chain, and logistics. Network with over 150 of your peers as we explore strategies to maximize efficiency while remaining compliant in […]
ICQ Total Benefit Compensation Package – Better Insurance and More time Off!
ICQ Total Benefit Compensation Package Did you know the average monthly premium for a family plan for health insurance nationwide is $833.00 per month? Since the passage of the Affordable Care Act, Americans who make a certain level of income and are without health insurance have been financially penalized. ICQ provides premium free health insurance […]
ICQ will be attending the 2018 ISPE Boston Product Show
The ISPE Yearly Product Show is a great place to network and get back in touch with colleagues you may not have seen in years. Stop in to see all of your friends and colleagues at ICQ. Please stop in a meet the folks from ICQ in the West Hall booth W68 at this years ISPE […]
Job Posting: Computer System Validation (CSV)
Job Posting: Computer System Validation (CSV) Duration: 6 months to 1 year Location: Greater Baltimore Area Education Requirements B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. Responsibilities Assist in authoring and revising procedural controls, assessment forms or checklists, associated process work instructions, and potential ERES training materials. Implement […]
Identifying System Boundaries in a few easy steps: so easy a cave man can do it!
Identifying System Boundaries in a few easy steps: so easy a cave man can do it! System boundaries are the foundation of the Engineering lifecycle. These boundaries identify where one system ends and another begins. System boundaries define the scope of a system and assist in the management of Validation, Maintenance and Change Management processes. […]
Resin Life Cycle Validation – An Important Factor in Any Validation Program
The purpose of performing resin life cycle validation is to demonstrate that the column resins for the process are capable of maintaining acceptable performance throughout the lifetime of the resin. It is also to demonstrate that the resin can be successfully cleaned and reused. The target number of resin cycles should be established through small […]
ICQ Consultants New Applicant Sourcing Platform with Client Portal…
ICQ Consultants is excited to announce its New Applicant Sourcing Platform with Client Portal. The ICQ Applicant Sourcing Platform is a cutting edge approach to sourcing, hiring and placement of resources that connects our recruiting team directly to prospective candidates and clients. It offers a live snapshot of ICQs career openings, projects, and hiring needs with automated workflows […]
ICQ Consultants New Applicant Sourcing Platform with Career Portal…
ICQ Consultants is excited to announce its New Applicant Sourcing Platform with Career Portal. The ICQ Applicant Sourcing Platform is a cutting edge approach to sourcing, hiring and placement of resources that connects our recruiting team directly to prospective candidates and clients. It offers a live snapshot of ICQs career openings, projects, and hiring needs with automated workflows […]