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rajashri ojha
Registrace 27. 03. 2012
Indian MDR 2017 Rules AND ISO- 13485 2016 QMS by Rajashri Ojha lecture
Indian MDR 2017 rules AND ISO 13485 2016 QMS by Rajashri Ojha lecture
According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017
According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017
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Video
ABOUT RAAJ GPRAC & RAAJ PHARMAELEARNING 2024
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ABOUT RAAJ GPRAC & RAAJ PHARMAELEARNING 2024 SUCCESSFULLY TRAINED MORE THAN 45000 CANDIDATES ACROSS THE GLOBE. AWARDED AS WOMENS OF EXCELLENCE -2024
video2483913120 -FAQ-Question and Answers about RA Career Guidance
zhlédnutí 79Před 2 měsíci
FAQ- Frequently ASKED QUESTIONS TO BECOME A REGULATORY AFFAIRS PROFESSIONAL. “Pharmaceutical regulatory affairs (RA) are a critical function within the pharmaceutical industry that focuses on navigating the dynamic and highly regulated landscape of regulatory requirements to ensure the development, approval, and ongoing compliance of pharmaceutical products.” The multifaceted role of regulatory...
video1483913120 Navigating RA profession through Pharma and Healthcare
zhlédnutí 212Před 2 měsíci
Dear All, Thanks for joining todays webinars on 'Navigating RA profession through Pharma and Healthcare sectors' by Rajashri ojha We are thankful to one of you for your kind attention and Excellent feedback given to us. Considerations and Requirements for Different domain in Regulatory Affairs Regulatory Affairs Regulatory Operation Labelling Different Dosage forms Different Drug Regulatory Aut...
ABOUT RAAJ GPRAC & RAAJ PHARMA E-LEARNING!!
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ABOUT RAAJ GPRAC & RAAJ PHARMA E-LEARNING!! VISIT AT OUR WEBSITE AT WWW.RAAJGPRAC.COM WWW.RAAJPHARMAELEARNING.COM
cGMP day lectures at NMIMS-10Oct23 Part 1 by Rajashri Ojha
zhlédnutí 211Před 9 měsíci
cGMP day lectures at NMIMS-10Oct23 Part 1 1,200 GMP Guidelines in the database The European Compliance Academy [ECA] has developed a database which contains more than 1,200 GMP Guidelines from all major authorities such as the US FDA, the EU/EMA, the PIC/S, ICH, and many more. The GMP Guideline Manager is available at no cost for all ECA Members. ECA Members can access all Guidelines through th...
video3416680026 GMP AUDITOR COURSE AT RAAJ GPRAC 2023
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GMP AUDITOR COURSE AT RAAJ GPRAC 2023
Webinars on GLOBAL Regulatory bodies Raaj GPRAC
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Webinars on GLOBAL Regulatory bodies Raaj GPRAC USFDA EMA- Europe PMDA- JAPAN UK MHRA TGS- Austalia ASEAN countries like Singapor, Malsia, Thialand, Phillipines, Combodia etc CIS countries like Russia and Kyrgkistan, Armeia, Turkmenistan and others
Raaj GPRAC GMP AUDITOR COURSE in Pharma industry
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Dear All, We are pleased to inform you about Raaj GPRAC courses in Pharmaceuticals, Nutracueticals and Medical Devices. Please contact us for more details and visit our websites at www.raajpharmaelearning.com
EMA -European Regulatory Lectures 11 Feb2022 2022 by Rajashri Ojha
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EU Regulatory system lectures along with eCTD submissions by Rajashri Ojha Please contact me or write to us at rajashrio@gmail.com
Medical Devices regulatory literacy & How to bring MD into market-A step by Step guide by Rajashri.
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-Brief Overview of ‘How to bring a Medical Device into market?? - Where Do I Start? -From Ideation, Market research, Finance, Design Development, -Design Control, Design Transfer, DHF -QMS, Reg Submissions, till Product launch -Regulatory Plan/Regulatory Strategies [US, EU, INDIA ] -QMS Implementation -Quality & Culture -How can we be Quality compliant-ALL THE TIME? -Responsibilities for each E...
Lectures on Indian MDR-2017 and MDD to MDR- Raaj GPRAC
zhlédnutí 113Před rokem
INDIAN MDR-2017 Salient Features of MDR-2017 Drugs and Cosmetics Act 1940, Rule 1945 Thanks, Rajashri Ojha Founder & Director #medicalcollege #medicaldevice #qualityassurance #biomedicalengineer #opportunities #development #marketresearch #medical #design #qualityassurance #regulatoryaffairs #qualitycontrol #medicaldevices #mechanicalengineering #mdr #eumdr #fda #submissions #learninganddevelop...
CAPA Effectiveness training in Marathi April2022 by Rajashri Ojha
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CAPA training to Marathi Employees April2022 #api #biologics #pharma #capa #qatar2022 #qualityassurance #quality #regulation #marathi #learning #job #onlinecourses #elearning #deviation #changecontrol
CMC P-part for Drug Product as per ICH CTD eCTD-By Rajashri Ojha
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CMC P-part for Drug Product as per ICH CTD eCTD-By Rajashri Ojha #raajgprac #onlinecourses #elearning #pharma #medicaldevice #nutraceutical #GMP #qualityassurance #qualitymanagement #compliance #job #skillindia #regulatoryaffairs #formulation #API #biologics #documentation #medicalwriting #clinicalresearch #pharmacovigilance #auditing #ctdectd #regulation #fresher #professional #advancecourse #...
Want to become a skilled Professional in Pharmaceuticals, Medical Devices and Nutraceuticals field?
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Want to become a skilled Professional in Pharmaceuticals, Medical Devices and Nutraceuticals field? RAAJ PHARMA will help you to build your career. Our courses are designed in such a way that the student will gain complete knowledge on the topics with the help of ppt, guidelines and videos We have designed courses which are skilled job training programs and provide knowledge to become expertise...
Audit closing meeting with AWARENESS Training as per ISO 13485-2016 for Medical Devices by Rajashri
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Audit closing meeting with AWARENESS Training as per ISO 13485-2016 for Medical Devices by Rajashri
RAAJ GPRAC Student Testimonial-Thippeswamy -2022
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RAAJ GPRAC Student Testimonial-Thippeswamy -2022
video1119629644 Career guidance in Pharma, Nutra and Medical Devices by Rajashri Ojha
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video1119629644 Career guidance in Pharma, Nutra and Medical Devices by Rajashri Ojha
LABELING in Pharma as per India-USA and EU regulation-lectures by Rajashri Ojha
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LABELING in Pharma as per India-USA and EU regulation-lectures by Rajashri Ojha
1-How To Implement MDSAP ( Medical Device Single Audit Program)?
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1-How To Implement MDSAP ( Medical Device Single Audit Program)?
GDP Good Documentation Practices by Raaj Pharma eLearning
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GDP Good Documentation Practices by Raaj Pharma eLearning
Risk Management in Marathi March 2022-by Rajashri and Arvind
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Risk Management in Marathi March 2022-by Rajashri and Arvind
ISO Lectures Jan 2022 2022 02 17 21 40 GMT 8
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ISO Lectures Jan 2022 2022 02 17 21 40 GMT 8
Lectures on Career guidance for BSc MSC B Pharm M Pharm B Tech M Tech Life Science students
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Lectures on Career guidance for BSc MSC B Pharm M Pharm B Tech M Tech Life Science students
EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning
zhlédnutí 8KPřed 2 lety
EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning
LECTURE ON PHARMA REGULATORY AFFAIRS DEC-2021
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LECTURE ON PHARMA REGULATORY AFFAIRS DEC-2021
Anil jauhri n M Jenna Speech during 5th batch inauguration at Raaj GPRAC
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Anil jauhri n M Jenna Speech during 5th batch inauguration at Raaj GPRAC
Certificate QA course for Biomedical engineers n Overview of Global MD Industry
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Certificate QA course for Biomedical engineers n Overview of Global MD Industry
Worthy
Thank you so much! helpful for interview
Which is best Pharma regulatory affair formulation or regulatory affair in medical device in terms of salary and work life balance.
What is the scope of RA cosmetics?
nice and informative lecture
one question: under which change type is the changing of the container of infusion solution( glass bottles ) to ( infusion solution packs? is it type II or IB ?
you cant imagine that your lectures are making a huge difference in my career life.i am really understand your lectures more than the training I am getting in my company . but hope they are in English
cant thank you enough for this very good presentation ( you are very experinced in RA )
informative.
Mam calculated 3*3 on somewhere and it said it loudly, sorry😅 i was listening ur lecture with full concentration thats why i noticed it😂
thanks a lot for such a valuable presentation or Article
Hi, May I know when eCTD (Electronic Common Technical Document) implemented in India ?
Thanku so much mam
Mam I am studying bpharmacy 4th year I am currently doing my project work ..I am thinking to complete my project on regulatory affairs i because I am very interested in RA can you please guide me to complete my project by giving an particular topic so that I can learn the basics of RA
Could you please provide the various courses discriptions.. Like for how long term courses are?
where to buy her online courses
Thank you for this detailed teaching.
Really it's wonderful video ma'am... superb explanation with clear voice... please make more videos ma'am
Thanks mam. I appreciate you; I think you were not feeling well during this session, but you studied in a good way... thanks a lot.
It will be a great help for me
Mam can i have those documents you showed?
Nice explained, I need to understand p. 5.5
*promosm*
Mam hindi m video dalo aap bhaut helpfull video dalti ho
ok noted
Yes its explained during our course training. Please join our courses and you will have more knowledge and skills. Send me your CV , email id and WhatsApp number to share the details. My number is +91 9819125208
It's video was very helpful
Marathi ajun vedio banava
Khup chan
Thanks
Very motivative and important session this is !!! Thank you mam for sharing such a sessions
Thanks Shubham for your kind words.
Wonderful content. Thank you for making it available to us.
Mam i need tga for australia, can you help me about this?
Dear madam Please can we have ur video in English
very nice presentation.
Thanks for your information
Thank you so much madam, it helped me alot.
👏
Very nicely explain.......🙏🙏🙏🙏👍👍
Could you please provide Regulatory CAPA examples?
yes its given during our course training. Please join our courses and you will have more knowldge and skills. Send me your CV , email id and whatsapp number to share the details. My number is +91 9819125208
Do we have examples of CAPA in RA?
Madam, how can we register for your training program?
Hi, please give me your email id and whatsApp number to share details. Also visit our website at www.raajpharmaelearning.com to get ONLINE COURSES from ANYWHERE AT ANYTIME
Thanks for your kind words, Please watch other videos as well and give your feedback. Rajashri Ojha-9819125208
Very nice presentation mam. Very useful and I will share this to the persons who are working in the industry and thinks that labelling is not important. Love this presentation 👍
Thank you Ma'am Very Informative
Mam... Thank u very much for your explanation with Very simple english
Useful video. But 8.45 the slide has typo; Wrong heading, it is not M2; it is 32S. And subsection numericals are also wrong.
Very well explained mam 🙏
Please share the link of previous session on EUrope appovel time lines
Thanks ma'am, very nice. Will u please share previous video link
Thank you! very nice. Could you help me the following query: major difference between Type II variations via NP and MRP/DCP?
Wow super mam👍💯