Congratulations to John Michael McCants, CGMP, TMP who is now CGMP certified! He attended the Society of Government Meeting Professionals (SGMP) National Education Conference in Omaha, Nebraska last week where he took part in the Certified Government Meeting Professional (CGMP) boot camp. Being #CGMP certified means that he now holds the highest designation available to government meeting professionals. We're proud of John Michael and his dedication to learning and growing professionally. #MeetCharleston #CGMPCertified #CharlestonSC
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"Reading SOP is not Training" that is correct, although it may fall under Awareness or Familiarization, if effectiveness is not evaluated then ther is no assurance that it will achieve its intention. #gmp #fda #cgmp #training #awareness #Familiarization #MuhammadFahmy #effectiveness #effective #evaluated #evaluation
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Tenacious Training, Communication, Public Relations, HR & Organizational Development Leader experienced in regulated pharma, nutraceuticals, medical device, healthcare technology & software development environments.
I’ve been saying this for 20 some years; how many FDA training related observations does it take for companies to see this & invest in appropriate training? All regulatory authorities are looking for both knowledge transfer & proficiency demonstrations or OJT qualifications documenting effective employee training…
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Exactly! Training, including your annual GMP training should not be the same set of slides year after year. Same compliance requirements, same processes, etc but the message should be delivered in a way that has meaning to the audience. Are we simply checking a box or assuring our teams have the tools to succeed and understand why it is a requirement? Great FDA topic!
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Sharing best practice is one of the key to explore an effective way of training including success control (Quiz, OJT) 💡
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Founder of the OSICS network: the Pharma operations performance transformation experts / McKinsey, Toyota, GSK & Teva Alumnus
At The OSICS Network we understand and agree with this 100% - yet this is too often the practice and then people go on the job and learn from others with often doubtful qualification approach. The results are often seen in lack of performance of the site or the area with too many rookies that learn the job and the equipment on the go: more deviations, downtime, failed batches, excess waste… We have partnered with HAPSTER in the pharmaceutical space to take operator training and qualification to the 21st century: Capturing know how and learning maturity increase before you go “live” on the job has never been so easy. In some jobs you take the qualification times from months to weeks or weeks to days even more in complex jobs where know how is key. Reach out to us to understand more what we could do for you and your training solutions. Franck Vermet #pharma #training #knowhow
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Reading SOPs is not training...
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Training from bottom to up. So it is more like evolving while revolving we all spin the quality wheel at a critical pace and involve everybody at workplace. It will be more like the nerve impulse phenomenon. if we want a best quality we involve all else if we include some or none we compromise quality. SOP is the revolving Wheel of Quality.
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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2 Million+ Reach|CEO|Director at Gitchia |IMEC|Beyond Tech|The Cafe,Needz|QMS|MDQMS |EnMS||HFMS|FSMS||AIMS||MDR||GDPR|FSSC 22000|BRC 9|NEBOSH |GHG|AI Generatv|17021|17024|17025|17065| 17034|PS 4992|GBT Assessor|Total:267
Honored to receive the FDA bioavailability and inspection of Good Lab Practices GLP Certification through webinar! 🌟 Thrilled to have successfully completed the FDA Good Laboratory Practice (GLP) training, enhancing my expertise in ensuring quality and integrity in laboratory research. Special thanks to FDA. Excited to apply this knowledge in industries/auditing to drive innovation and excellence. #FDA #GLP #QualityResearch #ContinuousLearning
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Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Amplifying voices for the future of Life Sciences automation | Head of Communications for Skellig Automation
Correct. Reading SOPs doesn't even come close to passing muster. "I read and understood this SOP" is not a sufficient measure of understanding, but a great way to see how good someone is at clicking on something before a deadline. I've designed and administered a lot of training in my day, and none of it means anything without some kind of testing at the end. Even then, repetition is key. It takes 5-7 repetitions to move something from short-term to long-term memory.
Guidance to compliance - we support your GMP coverage! Current, practical & inspection proved.
"Reading SOPs is not training." This powerful statement echoed throughout several Q&A sessions with the FDA at the 2024 PDA/FDA Joint Regulatory Conference. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. FDA representatives stressed that effective training is a cornerstone of GMP compliance. However, they cautioned against repetitive, ineffective training. A key takeaway? Failures often stem from shallow root cause analyses, signaling that quality management systems may not be fully embraced in practice. As Douglas Throckmorton from the FDA put it, "We are in the age of quality." Every employee must take ownership of quality, from the ground up. Patrizia Cavazzoni added, "Senior leaders are the most important ingredient. They set the tone!" Clearly, proper GMP training and performance monitoring remain areas of focus during FDA inspections. Reporting from the 2024 PDA/FDA JRC - Thomas Peither, GMP-Verlag Peither AG | GMP Publishing, Inc. #PDAFDA #PDA #gmp #cgmp #gmppublishing #gmpverlag #FDA #quality
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Congratulations John Michael 😎