Training Credentials – Training Course Badges
Training Credentials and GMP Training Certificates: GMP Training Course Badges Finishing a well-recognised qualification from a notable education provider doesn’t mean you actually understand what it’s really like to work in a particular industry. Certainly, in the life science sector, a University degree is one of the more imperative training credentials you will need to […]
PIC/s Annex 2A for ATMPs – GMP Regulation Updates
This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good Manufacturing Practice (GMP) requirements for Advanced Therapy Medical Products (ATMPs). PIC/s guidance on ATMPs and biological medicines: what changed in PIC/S Version 15? GMP requirements for the production of ATMPs (in Annex 2A) are now in a […]
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How do you ensure your organisation is ready for an audit? Do your employees know how to properly respond to an Auditor’s questions? Or was your last mock GMP audit (or internal quality audit/self-inspection) a disaster? If you’re […]
Remote Auditing Guidelines
Remote Auditing Guidelines and Procedures for Remote Audits (ICT, Security) Remote Auditing Guidelines: 10 Commandments for Conducting Remote Audits and offsite inspections Frequently asked questions about Remote Auditing techniques, procedures and guidelines FAQ1: Are remote audits as effective as onsite audits and site inspections? The success of a remote audit depends on numerous factors, including […]
Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If yes, there are 5 essential skills you’ll need to develop to be successful in your employment. The pharmaceutical sector includes medical device manufacturing, biologic medicines, veterinary medicines, medicinal cannabis cultivation and production, and certain nutritional supplements and […]
Best Practice Online Assessments: Top 5 Tips
Demand for best practice online assessments increased rapidly in 2020, as the education sector reacted to the impacts of the pandemic. While Covid lock-downs and travel restrictions had a devastating impact on a wide range of industries, the education sector was hit particularly hard. Fortunately, industry growth trends are expected to continue despite the initial […]
Zoom etiquette: virtual training delivery
ZOOM etiquette and Zoom Meeting DO’s and DON’TS made all the top 10 blog topics lists (2020-2021). In 2021, Zoom etiquette continues to be a dominant blog theme. These virtual meeting platforms are here to stay, especially with travel restrictions likely to continue for at least the next two (2) years (or longer). As the […]
MHRA GMP Audit – Summary of 2019 – 2020 Inspections (PQS deficiencies)
Top 10 MHRA GMP Audit deficiencies (2019 – 2020 analysis) Summary article for Education Purposes only. If you are facing a GMP audit by the MHRA, you’ll want to ensure ALL of your quality systems are fully compliant with current Good Manufacturing Practice (cGMP). That noted, which components of your pharmaceutical or medical device quality […]
HVAC system specifications and requirements: pharmaceutical manufacturing
When it comes to HVAC system specifications and requirements for pharmaceutical facilities – including cleanroom designs – getting your HVAC system right is crucial for product quality and GMP compliance. If your pharmaceutical facility architects (or construction managers) do not fully understand GMP, you’re risking product contamination issues and future GMP inspection findings (GMP audit […]
Cannabis Cultivation Training: 2 Convenient Options
Cannabis Sector Insights and Cultivation Training Cannabis Sector Speaker Presentations from the Global and Asia-Pacific Medicinal Cannabis Conference For those of you who missed the world-class Australian Medicinal Cannabis Conference (#AMCC) in 2020, there are two (2) options available to you, your potential investors, and your operational teams in need of cultivation training expertise and regulatory […]
Software as a Medical Device (SaMD)
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with other medical devices, medical-use software offers potential benefits to patients. SaMD can save lives by improving diagnostic capacities, monitoring treatment efficacy, and guiding critical-care decisions. Review the online GMP compliance course for SaMD designers, medical-use software manufacturers […]
Good Clinical Practice (GCP) Inspections Program
New online courses available for clinical trials and GCP compliance training. The latest online training courses at www.onlinegmptraining.com relate to drug safety through GCP (clinical trials) and pre-and post-marketing pharmacovigilance (drug safety surveillance and adverse event reporting/SAE reporting). These courses cover pharmaceutical development quality management systems (QMS) and quality risk management (QRM), drug approval processes, […]