Thanks for the great service as always, robbie robinson. I also appreciate you taking such good care of my friend, Kirk Gimenez. If you need a safe, reliable, friendly, and professional car service when you're in DC, you can't do better than Robbie and his Loveable Little Car service.
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Hi David, Congratulations, and well done on this. To any future employers, David covered the following areas during this programme:
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation
- Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
- FDA medical device rules – medical device regulations & and guidelines
- GMPs vs ISO 9001:2015 – what’s the difference and why we use both
- Process validation and documentation – design and verification of manufacturing systems
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic and sterile manufacturing
- Supporting technologies – such as purified water generation, storage and distribution, clean steam, water for injection, storage and distribution
- Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application
- Working in a cleanroom environment – layout, classification, gowning and monitoring
- Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry
And as part of part of his end-of-module assignment, David completed a 1200-word report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients.
It included:
- The key requirements of a quality management system
- The cleaning validation sequence and how to determine cleanliness levels
- The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
- The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
- The generation, storage and distribution of pharmacopoeia grade Purified Water (PUW).
- The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment
Well done again.
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Once you've finalized and completed a closing, celebrate it! 🎉 You and your team put in the hard work and saw it through to the end, so make a point to congratulate one another for another successful closing and let others know too! 📣
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A touching tribute to a colleague who sadly recently passed away which meant he couldn’t be here to see his daughter go to prom. We knew we had to do something very special so between Hallam and his family we surprised her with Pete’s truck to take her to prom which allowed him to be with her on her special day. It was the least we could do for a very dear colleague. A big thank you to our driver Chris for arranging and Jess & Karen for allowing Hallam Express to contribute🖤💛
Betsy SimpsonDavid SimpsonSherine DennisSarah Branstonstephen GoodwinTim Cooper
Wow what a review. Thank you so much Debbie and Randy.
We're thrilled to hear you had a fantastic experience and appreciate your kind words. Your satisfaction means the world to us and makes everything we do totally worthwhile!
See you in 2025 :)
#grateful#HappyClients#thankyouforyoursupport