Please join us in supporting ICQ’s very own Victoria Hayes who will be the meeting host for the next New England PDA Dinner Meeting held on March 15th. “Microbial Contamination and Effective Facility Decontamination in the GMP Setting” will be held March 15, 2017 beginning at 5:30 pm and running to 9:00 pm at the Marriott Burlington, One Burlington […]
The Commissioning/Qualification and Validation Engineer position has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations. EXPERIENCE REQUIREMENTS All positions require a solid understanding of the requirements for working in FDA-regulated industries within one of or more of the following areas […]
Quality standards from all institutions are periodically updated. A system that was designed to meet the quality requirements of yesterday, may not meet the requirements of tomorrow. How will you respond when an agency asks your firm if you have complied with the updates? There are many factors in determining the best course of action, […]
On a previous project, I was tasked with facilitating the technology transfer of a commercial process from a customer site to the CMO manufacturing plant. The scope of the project was for the successful implementation of the upstream process into a three (3) train, 5000L working volume production suite. Prior to undertaking the project, the […]
ICQ Consultants will be sponsoring a table at the next PDA Dinner Meeting, “Global Inspections and Trend”. Please join ICQ in attending this meeting held on Wednesday, November 9th at 5:30 P.M. running until 9:00 P.M. This session will be held at the Hilton Boston / Woburn, 2 Forbes Road, Woburn, MA 01801. Ann McGee of […]
Please join ICQ in attending the next NEPDA Dinner Meeting on May 18th. The event titled “Clean-rooms and Environmental Monitoring – Where Should We Be Going?” and “Contamination Control Case Studies” will be held Wednesday, May 18th from 5:30 – 9:00 P.M. at the Marriott Burlington, One Burlington Mall Road, Burlington, MA 01803. The event […]
According to 21CFR, 601.2, as cited in the Guidance for Industry Document, Analytical Procedures and Methods Validation of Drugs and Biologics (July 2015)1,2, biologics license applications (BLAs) must include a full description of the manufacturing process, including analytical procedures that demonstrate the product meets prescribed standards of identity, quality, safety, purity and potency. The purpose […]
Everyone at ICQ would like to thank you for visiting with us at the PDA Dinner “Evaluating Contract Manufacturing” on March 9th. This event had a great turnout and was quite the success. Thank you everyone for taking the time to attend and to all of those who dropped by and spoke with us. ICQ […]
Please join ICQ in attending the PDA’s event this evening. “Evaluating Contract Manufacturing” will feature talks by Amnon Eylath and Andre Merza with the presentations concentrating on evaluating contract manufacturing for Biotech and Cell and Gene Therapy and Risk Analysis of Non-Conformances in Research Model Production. This event will be located at the Boston/Woburn Hilton, […]
ICQ Consultants will be sponsoring a table at the 23rd ISPE CaSA Life Sciences Technology Conference in Raleigh, NC. The event will take place on Thursday March 31st starting at 9:00 A.M. through 7:00 P.M. and will be held at the Raleigh Convention Center. This event features many different speakers and will feature different […]
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