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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, […]

By |March 20th, 2019|Categories: Uncategorized|Tags: |0 Comments

GMP and Product Development Phases

Thousands of biotech pharma companies are conducting excellent research for the development of novel medicines for existing and unmet needs. According to clinicaltrails.gov, there are at this time more than 115,000 clinical trials being conducted in the US alone with around 22,000 studies in pre or clinical phase 1, 29,000 in clinical phase 2 […]

By |February 18th, 2019|Categories: Uncategorized|Tags: |0 Comments

Statistical Process Control, Friend or Foe?

In my experience, I see a lot of companies using trend charts and statistics to get a view of their process, when what they are actually doing is avoiding looking at their processes and waving meaningless numbers around.  While this doesn’t seem to make sense, when I look at the misuse of the data, […]

By |January 24th, 2019|Categories: Uncategorized|Tags: |0 Comments

21 CFR Part 11 Compliance Summarized……..Simply

21 CFR part 11 can be summed up in three words: Verify, Audit, and Track with one guiding compass, honesty. Companies must be able to prove without a shadow of a doubt that any person taking any action within a system is who they say they are. Any action taken within a given environment […]

ICQ Consultants is Hiring!

ICQ Consultants is hiring for multiple positions across the country.  Check out our Indeed Page and our GlassDoor Page and apply for one of our jobs to work for a great company today!  Use our Careers Page to apply for general consideration or any of our open positions and an  ICQ Recruiter will reach […]

By |November 30th, 2018|Categories: Uncategorized|Tags: |0 Comments

ICQ will be attending the 2018 ISPE Biopharmaceutical Manufacturing Conference in CA

The 2018 ISPE Biopharmaceutical Manufacturing Conference focuses on the quickly evolving science of biologics manufacturing for new modalities. From leveraging existing capacity with novel processes, to implementing new and emerging technologies, this conference will bring together experts and leaders to ensure the Biomanufacturing industry successfully prepares to manufacture these novel medicines to deliver on our promise […]

By |November 29th, 2018|Categories: Conference, Uncategorized|Tags: , |0 Comments

Getting Smart with Utilities Sampling

In the pharmaceutical industry utilities sampling is done for a number of reasons such as regulatory requirements, quality control, process control, investigational purposes, diagnostic purposes, or Test Method Validation to name a few.  Therefore it is important to understand what a sample is and why they are important. Simply put, the purpose of sampling […]

By |November 16th, 2018|Categories: Uncategorized|Tags: |0 Comments

ICQ will be attending the 2018 ISPE Annual Meeting & Expo in PA

The 2018 ISPE Annual Meeting & Expo is a four day event for professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services, suppliers, and regulatory professionals.  The expo will feature an extensive expo hall with more than 300 companies […]

By |October 25th, 2018|Categories: Conference, Uncategorized|Tags: , |0 Comments

Job Posting: Automation Project Manager/Engineer, Greater Baltimore Area

Job Posting: Automation Project Manager/Engineer Duration: 6 to 9 months, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater Baltimore Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Manage the automation & construction project scope including budgeting, project management, resource allocation, integration, […]

Job Posting: Computer System Validation (CSV), Greater Baltimore Area

Job Posting: Computer System Validation (CSV) Duration: 3 to 6 months, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater Baltimore Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, […]