Dr. Rupali Paranjape PhD’s Post

Whenever I visit the ocean and look at the waves I feel that like the Ocean the world of Compliance is also so deep..... Only working superficially won't help you. Dive into the Blue Ocean of Compliance! Uncover new horizons in pharma. Working superficially means? Working superficially means only preparing at the time of Audit not every day practicing. So be in the Blue Ocean of Compliance and don't work for only survival. Do you agree with me? Write me at rupali@blueoceancompliance.in www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape

Compliance is the way of living. Do not try to bind it with the boundaries of guidelines. It's limitless...... Nature has a tremendous energy to heal you... Hello, Compliance and Quality Professionals spend some time with Nature. I have seen many Quality and Compliance professionals suffering from the stress of Compliance... Suffering from the stress that people do not listen for compliance and in audit it's difficult to justify other's disagreement to follow the discipline called Compliance. Not only that but stress of finding the ways to win the game of timeline with Quality and Compliance. Let me tell you that Compliance is the way of living. Do not try to bind it with the boundaries of guidelines. Its limitless...... Do you agree with me? Write me to know more about Compliance on rupali@blueoceancompliance.in www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape, #readers, #India

What do you think about why companies fail in the audits? As someone does not know the compliance? OR someone does not want to follow the compliance? OR there is a lack of awareness? OR what? Whatever may be the reason it is sure that there is some basic difference between the thought process of companies who qualify for the regulatory inspection with no-observation and between the companies who fail in the inspection. Right? I have case studies of my clients who qualified for Regulatory Inspection with no -observation. I proudly say that out of those someone has walked a very far distance. Took their level of compliance to much higher than they used to be. So it's all about your attitude, the way you think, the way you want to live, the way you want to do your business. Finally, it's your life. Do you agree with me? www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape

The success of life lies in the direction..... Your complete life is just the result of the direction you choose.. We reach the destination based on the direction we choose... Do you want to do surfing on the waves of regulations and reach some destination for manufacturing good quality Medicines? Do you want to qualify for the Regulatory Inspection with no-observation then Blue Ocean Compliance can be your navigator. To win in the audit Blue Ocean of Compliance can navigate you to reach your dream destination. You may be a pharmaceutical company or you may be some pharma professional. After all this life is nothing but moving in the right direction at the right time. Compliance can navigate you to the direction of manufacturing the good quality of products. And if your product quality is good then you will qualify any audit effortlessly. If your product can save the life of a patient with no additional harm to him/her then you will not have to worry about qualifying audits.... But it will become your destiny.... Do you agree with me? #cgmp, #facilitydesign, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityassurance, #qualitycontrol, #qualityculture, #quality, #regulatory, #manufacturing, #ceomindset, #ceoinsights, #audits, #auditor, #compliancesolutions, #calibrationservices, #sops, #procedures, #cleaningservices, #analytical, #validation, #laboratory, #21cfrpart11, #dataintegrity, #documentation, #gdprcompliance; #traininganddevelopment ; #trainingneeds; #trainingtips; #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #womeninscience #womeninleadership #womeninbusiness, #tedx, #tedxtalk, #tedxspeaker

Many Companies got Warning letters as the Method was not validated. Many companies got Warning Letters as the process was not validated. Why? You cannot see the world if your eyes have some serious problem. You cannot win a race with a broken vehicle. You cannot run a race with broken legs. You cannot rely on the results if your method is not reliable. You cannot get the best outcome if your process is not validated. Do you agree with me? Want to learn the wisdom of Compliance? Write me at rupali@blueoceancompliance.in www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape

Q. 1 Whether you are facing difficulty in making people understand that any change cannot be done just as such? Q.2 Facing difficulty in making them accept that they have to follow the change control procedure? You may make them agree with you by making them understand the following few things; 1. Any change even if it's very small in your opinion may differ from the point of view of some other department. As in your department, it may be a small change but in another department, it may be a major or critical change and hence impact. 2. You may not be the right person to make the decisions on behalf of another department. 3. In case you don't take change control other departments even will not be able to know that the change is going to happen. Then how they will give their input and how anyone will tell you how it impacts other departments compliance and what activities to be done? And no CFT will be there. 4. We cannot do any change in the submitted Dossier/DMF/ documents/procedures/processes without evaluating its impact on submission. 5. For change in submitted Dossier/DMF/ documents/procedures/processes you will have to see its category in that country. For Europe-Type IA, IAIN, IB, Type II Variations. For US-CBE, CBE30, PAS Check whether the requirement your company can fulfill or not. Then decide whether to make that change or not. Apply this and tell me what is the impact. Till now whatever I suggested has given great results on the site to the people. Write me to learn more about Compliance services by Blue Ocean Compliance at rupali@blueoceancompliance.in www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape, #readers, #India

I have heard from someone that the same problem comes to you until you don't learn the lesson. It's very true in the world of compliance. In case you could not find the root cause of any deviation/incident/failure on your site. If you close the investigation and give some CAPA then your CAPA proves ineffective. This means you could not find the actual root cause of the problem, so that cause is still not resolved. So the same problem will come again and again till you do not find the actual solution to that. Like you are suffering from other diseases and taking medicine for some other disease. Then how your problem will be solved? Won't right? So if you have to work more, you need more time to investigate that time will be less than taking an ineffective CAPA which will take multiple years of your organization. Do you agree with me? With this approach, you may turn the obstacle on your site into an opportunity. By the way, till this date, I made each of my problems the reason for my success. Blue Ocean Compliance is a thought process. Which can solve many of your site's problems with a single thought. Want to learn how and work with me ? Write me at rupali@blueoceancompliance.in So stay tuned..... www.drrupaliparanjape.com #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #cgmp, #pharmaindustry, #ceos, #founders, #manufacturers, #pharmaceuticalindustry, #qualityculture, #quality, #manufacturing, #ceomindset, #ceoinsights, #traininganddevelopment ;  #ceoaction; #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #mpharm, #bpharm, #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape, #readers

Precision in #TemperatureMapping is key to #Pharma success. Ensure regulatory compliance, maintain product quality, and optimize storage conditions. Protect your investments with accurate mapping. #QualityControl #Compliance

Regulatory Affairs is a rapidly evolving landscape - and new advancements and trends are continually shaping the future. Is your organization tapped in for success? Explore our deep dive into the latest developments in Regulatory Affairs to stay ahead of the curve and expect what's next: https://lnkd.in/e-ZHjr-4 #RegulatoryAffairs #LifeSciences #PharmaTech #Innovation #Compliance #RegulatoryTrends #HealthTech

Blue Ocean Compliance Tips Roar with confidence in compliance! Be the lion of regulatory audits. To get the confidence you will have to work to win instead of survival. To work to win you will have to apply the strategy that is not to prepare for an audit. You won't prepare for an audit if you are ready to be inspected anytime. You will be ready to be inspected at any time if you will do every act in compliance. You will do every act in compliance if your main goal of manufacturing the medicines is to heal the patient/ to save the life of people. Do you agree with me? #cgmp #facilitydesign #pharmaindustry #ceos #founders #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #ceoinsights #audits #auditor #compliancesolutions #calibrationservices #sops #procedures #cleaningservices #analytical #validation #laboratory #21cfrpart11, #dataintegrity, #documentation, #gdprcompliance; #traininganddevelopment ; #trainingneeds; #trainingtips; #ceoaction #ceoagenda; #foundersday; #founderstory; #owners, #ownersrepresentative #collegesanduniversities #pharmacycollege, #mpharm #bpharm #pharmacy, #mpharm, #drrupaliparanjape, #blueoceanofcompliance, #rupaliparanjape #womeninscience #womeninleadership #womeninbusiness, #tedx, #tedxtalk #tedxspeaker #india,