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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…
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,…
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…
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…
Our highly qualified consultants have taken on management positions, such as Quality Director, Quality Assurance Manager and Compliance Specialist for pharmaceutical and biotech companies. Assignments include interim positions until the right employee is hired to fill the role, coaching junior…
On 25 January 2023 it’s #BellLetsTalk Day, so on this day and every other day, let’s take steps to make a difference in mental health issues and create positive change. https://letstalk.bell.ca/
The key to having a successful regulatory inspection is Preparation. One of the best ways to prepare your facility for a regulatory inspection from Health Canada, FDA, ANVISA, EMA or any other regulatory agency is to perform a Mock inspection.…
Health Canada, FDA and other Regulatory Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated with such systems. It is important for companies to execute comprehensive…
GMP Consultants are engaged with clients on long term basis from several hours / week to multiple days / week to assist teams with the following tasks (to name a few);
GMP Consultants have supported many large and small Pharmaceutical companies to reduce their Deviation, Change Control, and CAPA backlogs. We also provide training on Deviation Processes and Human Error Reductions to help reduce the number of deviations initiated.
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