Activities / Industry News / Social Responsibility
The 2024 “Challenge of the Brave” event will be held on Saturday, April 27th. Everyone is invited to join the BBQ and festivities (raffle, games, music, awards) at Meades Park & Sports Complex, located at 16950 Hymus Blvd. in Kirkland.…
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FDA is hosting a 3-hour webinar on Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards on November 7, 2023. The purpose is to provide the pharmaceutical industry…
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A total of $208,530.85 was raised for the West Island Cancer Wellness Center (WICWC) during the “Challenge of the Brave” event on Saturday, April 29, 2023. Elaine Gourlay, President of GMP Consultants and her team participated in the event as…
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If you’re like me, you travel for business meetings, conferences, audits, training or just pleasure, and your hotels or resorts provide you with a daily supply of small sized soap, shampoo, conditioner, toothpaste etc. And like me, you may not…
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FDA is hosting a webinar on Electronic Systems, Electronic Record, and Electronic Signatures on April 25, 2023. This is your opportunity to get information on FDA’s thinking regarding 21 CFR Part 11 and its application to electronic systems, records and…
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One of the many activities performed by GMP Consultants is Auditing. We average 10 – 12 audits / year. We have experts that are qualified to audit sterile and non-sterile drug manufacturers, APIs, packagers, labelers, testing laboratories, importers, distributors and…
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FDA has published Guidance “Q13 Continuous Manufacturing of Drug Substances and Drug Products“ on 1 March 2023 for Industry. The guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on…
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GMP Consultants routinely conduct GAP Assessments for clients. They can be general GMP Assessments to ensure that the company meets regulatory GMP requirements or they can be specific assessments, on topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services,…
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Many of us have been touched by Cancer—perhaps through a personal diagnosis—or by a family member, friend, or colleague diagnosed with the disease. The West Island Cancer Wellness Center (WICWC) is organizing an “Amazing Race” type event called “Challenge of…
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ICH has published a Revised Guideline on Quality Risk Management Q9(R1) on 18 January 2023. GMP Consultants can provide you with a word by word comparison of the 2005 vs 2023 documents. If you would like to purchase a copy…
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