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#Kaizen   #BPM #ContinuousImprovement  #QualityImprovement     #ManufacturingManagement #Pharmaceutical  #LifeSciences #Drugs #FMEA   #RiskManagement  #ErrorProofing #Losartan  #Irbesartan  #Valsartan

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp
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#Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement #LifeScience  #Food  #Beverage  

Kaizen Champion Certification Online Course is for Professionals at all levels of Management.

• Learn how to select Kaizen projects, strategize, design and implement Kaizen continuous improvement campaigns.
• Lean how to drive Kaizen projects successfully, create profits, reduce defects- overheads- errors, increase productivity- sales-market share- customer satisfaction. Take your company and career to the next level!
• Learn in-depth about 9 types of Kaizen viz. Gemba Kaizen, Lean Kaizen, Modular Kaizen, Blitz Kaizen, Flow Kaizen, Process Kaizen, Personal Kaizen, Daily Kaizen, Agile Kaizen and how each Kaizen type can help you achieve success with your Kaizen initiatives.
• The course has 6 Modules of self-paced study, training videos and instructor support, a Toolkit comprising 52 tools and 5 Case Studies that help you apply Kaizen to your organization.
• The course includes videos showing real-time application of Kaizen in 5 reputed companies in US and Japan.

Participants must complete Tests and Assignments associated with each Module. All tests and assignments are open book exams. Kaizen Champion Certificate shall be sent to participants once they complete all tests and assignments successfully.

After successful completion of the course, participants gain the vision, knowledge and capacity to drive Kaizen implementation in their organization.

​#Kaizen #KaizenChampion #KaizenCertification 

The workshop has 7 Modules of training videos and instructor support, a Toolkit comprising 52 tools and 30 Kaizen templates, that help you apply Kaizen to your organization. 

The workshop also includes 7 Case Studies of successful Kaizen implementation and includes videos showing real-time application of Kaizen in 5 reputed companies in US and Japan.

Participants must complete Tests and Assignments (open-book exam) associated with each study module; successful participants get a Kaizen Leader Certificate.

After successful completion of the course, participants gain the vision, knowledge and capacity to design Kaizen strategy and lead Kaizen implementation in their organization.

#Kaizen #KaizenLeader #KaizenForPharmaceuticals #KaizenCertification ​

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​#ContinuousImprovement #Kaizen #Workshops  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeSciences  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  

For the affected patients, it is horrifying to learn that they have unsuspectingly consumed a medicine that contains a potential carcinogen. In addition they have now to deal with product shortages; a product they consume daily to keep their blood pressure in check!

For pharma companies, this is a huge hit to their brand image as well as to their bottom-line. 

Even though Impurities in drugs and drug products are a part of manufacturing process, drug companies strive hard to keep them at minimal and within specifications; be it as per ICH, FDA or company's internal standards. So what happened in case of Valsartan, Irbesartan? Are compendial testing procedures adequate? How were these impurities missed?

Several such questions arise... A root cause analysis will dig into reasons for the lapse, but prevention is better than cure … this is more so true for defective pharmaceutical products. Lesson learnt from *SARTAN mishaps is as a wakeup call !

Recalls will surely stop patients from taking defective batches of Valsartan, Irbesartan. But what about the damage already done to patients who have consumed these defective products? And what is it that we must do to prevent something similar from happening again; not only for *SARTANs but any other drug or drug product?
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Impurities in drug/drug products: How NOT to miss them?

Pharma R&Ds follow rigorous procedures to keep impurities/ degradation products at minimal possible levels. Drugs and drug products are developed using high standards and elaborate regulated procedures, yet how were these impurities missed out? And what to do to NOT miss them?

Here's the starting point-

Drug and drug products are developed using ICH Quality norms, QbD (Quality-by-Design), PAT (Process Analytical Techniques) and similar such sophisticated guidances which facilitate 'risk-assessment'. Based on *SARTAN scenario, a logical question that pops up is- Are these 'risk- assessment' tools good enough? Or is there an application failure? In the former case, guidance documents need overhaul, while the later, points to inadequate training (around appropriate implementation of these guidances).​

​Impurities are consequence of drug/ drug product manufacturing process. Any potential carcinogenic impurity carry overs into medicinal products and patients is no doubt hazardous; but it doesn't end there. What about these carcinogenic impurities getting into effluent systems and perhaps into the environment? This puts a larger population at risk!

Existing IPQC, QA monitoring norms are not good enough when we deal with complex small molecule drug candidates. All processes (technical and/or operational) leading to the products must be studied comprehensively,  supervised, modified and improved 'Continuously' ...

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#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Losartan #Valsartan #Irbesartan #USFDA   #Quality  #eLearning  #ManufacturingManagement #Pharmaceutical  #LifeSciences   #LeanManagement  #KaizenMasterclass    #RiskManagement  #Impurities