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Pharma Learners
India
เข้าร่วมเมื่อ 28 พ.ย. 2017
Pharmalearners TH-cam channel is an informatory and educational channel for all pharma professionals.
Our aim is to prepare and shares pharma related small tutorials for both fresher’s and experienced pharma professionals.
So that you can learn and update your knowledge anytime anywhere.
We are continuously working to make this channel a knowledge hub for all pharma related technical information at one place.
Our channel will continuously providing you small tutorials on various domains of pharma industry and academia, including GMP, GCP, GLP, REGULATORY AFFAIRS and various current trends and regulatory guidelines.
If you have any suggestions for further improvement, please share with us:
Our aim is to prepare and shares pharma related small tutorials for both fresher’s and experienced pharma professionals.
So that you can learn and update your knowledge anytime anywhere.
We are continuously working to make this channel a knowledge hub for all pharma related technical information at one place.
Our channel will continuously providing you small tutorials on various domains of pharma industry and academia, including GMP, GCP, GLP, REGULATORY AFFAIRS and various current trends and regulatory guidelines.
If you have any suggestions for further improvement, please share with us:
Drug recall classes |Why are drugs recalls | Types of drug recall | Renitidine Recall | timelines
Drug recall classes, why are drugs recalls, types of drug recall, Renitidine Recall, levels and timelines of Recall
In this video tutorial you will learn about:
Drug recall classes including class I, class II and class III recalls with examples.Types of drug recall, various levels of drug recall,
Why are drugs recalled and recent examples of drug recall including Zantac recall by Sanofi which is also called renitidine recall because of FDA found N-nitroso-dimethyl-amine (NDMA) in some renitidine products which causes the Cancer.
Some other examples of Recall i.e. Vioxx recall, metoprolol recall by dr reddy's laboratories ltd. will be discussed in this video.
what are the Time Lines for Effective Recall System and Rapid Alert suggested by CDSCO.
____________________
In this video tutorial you will learn about:
Drug recall classes including class I, class II and class III recalls with examples.Types of drug recall, various levels of drug recall,
Why are drugs recalled and recent examples of drug recall including Zantac recall by Sanofi which is also called renitidine recall because of FDA found N-nitroso-dimethyl-amine (NDMA) in some renitidine products which causes the Cancer.
Some other examples of Recall i.e. Vioxx recall, metoprolol recall by dr reddy's laboratories ltd. will be discussed in this video.
what are the Time Lines for Effective Recall System and Rapid Alert suggested by CDSCO.
____________________
มุมมอง: 7 545
วีดีโอ
Marketing Authorisation in EU| European Medicines Agency (EMA)| MRP, DCP, CP & National Procedure
มุมมอง 24K4 ปีที่แล้ว
National procedure, Mutual recognition procedure, Decentralised and centralised procedure are the four marketing authorisation routes are granted in the European Union. You will get the details about European medicine Agency in European Union and how these marketing authorisations are granted in the Europe. You will also know about the: Marketing authorisation (MA), marketing authorisation appl...
Pharma Interview QnA |Delayed release vs Extended release vs sustained release, Targeted Release
มุมมอง 18K5 ปีที่แล้ว
In this tutorial you learn about What is the difference between Delayed-release vs. extended-release Formulation I also explained here about the difference between Sustained release, controlled release, prolonged release, modified release, targeted release and immediate release formulations.
ICH Impurity Guidelines| ICH Q-3|Key points to remember
มุมมอง 20K5 ปีที่แล้ว
ICH Q3 Guidelines key points to remember In this tutorial you will learn about What are the Various thresholds levels for impurities in DS and DP. Also explain you about reporting, identification and qualification thresholds. and Which guidelines should be referred for impurities.
3 stages and 4 types of Process Validation | FDA Guidance on process validation
มุมมอง 105K5 ปีที่แล้ว
Types and stages of Process Validation and US FDA Guidance on process validation. In this tutorial i will correlate the types of process validation with these three stages of validation suggested by the US FDA. There are three are stages of PV: The stage 1 is Process Design Stage 2 is Process Qualification and Stage 3 is Continues Process Verification. And there are total 4 types of Validations...
How to perform FMEA| Process steps and Risk Calculation| Failure Mode and Effect Analysis|ICH Q-9
มุมมอง 65K5 ปีที่แล้ว
FMEA in 9 Minutes. You will learn about how to perform FMEA, step wise process of performing FMEA. How perform the risk rating for severity, occurrence and detection for each failure mode and calculation of Risk priority number also called as RPN. When and where to use this FMEA tool.
Top 5 interview questions on Stability from ICH and FDA guidance.
มุมมอง 59K5 ปีที่แล้ว
In this tutorial, I will discuss about Top 5 frequently asked interview questions on Stability studies from ICH and FDA guidances. Here is the link of previous tutorials, For exhibit batch size requirements for ANDA Part-2: th-cam.com/video/93axDflz_oI/w-d-xo.html Part-2A: th-cam.com/video/IPt4gUb78Y8/w-d-xo.html To learn about significant changes. th-cam.com/video/EsFrZcA58CE/w-d-xo.html Q.1 I...
Pharmaceutical Interview Questions| Part-2A|Exhibit batch size requirements for Parenteral & TDDS
มุมมอง 6K5 ปีที่แล้ว
Pharmaceutical Interview Questions| Part-2A|Exhibit batch size requirements for Parental & TDDS In this tutorial you will learn about EXHIBIT batch size requirements for parenterals and transdermal(TDDS) preparations. according to the USFDA guidance.! I will explain the requirements with examples to make you understand this topic simple manner. In previous tutorial I have already discussed abou...
Pharmaceutical Interview Questions| Part-2|Exhibit batch size requirements for ANDA|Oral & topical
มุมมอง 24K6 ปีที่แล้ว
Pharmaceutical Interview Questions| Paert-2|Exhibit batch size requirements for ANDA. In this tutorial you will learn about EXHIBIT batch size requirements for solid oral, liquid orals and topical preparations. according to the USFDA guidance.! I will explain the requirements with examples to make you understand this topic simple manner. In previous tutorial I have already discussed about the s...
Pharmaceutical interview questions on ICH stability guidelines|Part-1
มุมมอง 39K6 ปีที่แล้ว
What is Significant Change in Pharmaceutical Stability Testing? Or Can you explain what do you mean by significant changes? This is the one of the frequently asked question in the interview. In this tutorial you will learn how to define “Significant change” in a drug product or drug substances, according to ICH Q-1E guideline.
Para four filing procedure, and 180 days Exclusivity
มุมมอง 17K6 ปีที่แล้ว
Para four filing procedure, and 180 days Exclusivity When patent is not expired and ANDA applicant intends to market its generic version, prior to expiration of the patent, applicant files the application with Para four certification. While making Para four filing application, ANDA applicant proclaim that either patent is invalid not infringed or it is unenforceable. In this tutorial I will dis...
Import Alert | Examples and categories
มุมมอง 3.4K6 ปีที่แล้ว
FDA issued the import alert whenever FDA finds that, it already has sufficient evidence to conclude that your products appear to be adulterated, misbranded, or unapproved, and that therefore they may be refused admission. There are various categories of import alert which is discussed in this tutorial with examples. FDA webpage link for Import Alert. www.accessdata.fda.gov/cms_ia/default.html
FDA form 483 and Warning Letter| What is the difference?
มุมมอง 27K6 ปีที่แล้ว
FDA form 483 and Warning Letter| What is the difference? In this tutorial, you will learn about: What is FDA Form 483 and Warning Letters. What's the difference between form 483 and Warning Letters. What FDA Expects from companies. and some questions for your assessment on this topic.
Top 10 Indian Pharma companies and their Founder's
มุมมอง 14K6 ปีที่แล้ว
Top 10 Indian Pharma companies and their Founder's In this video you will find the Top 10 Pharmaceutical companies of indian origen and come to know that who had founded the companies.
useful, but audio quality could be better
Stop background music, unnecessary stupidity
How can i Register my Pharmaceutical Products in EU
For more understanding you should give the one example for this. Thank you.
Informative 😊
483 True
Good information
Audio is having too much base & subtitle is typing something which cannot be related to the conversation. good video, very hard to understand with the audio issues
Sir, can we get your contact details.
Thank you sir, good information. Please upload vedio on mock recall procedure and documentation.
Mock recall generally be carried out for at least one batch of any product, dispatched for sale where maximum distributors are involved, to test the effectiveness of the arrangements of recall. The effectiveness of the recall procedure can also be checked by ‘evaluation of a real recall’. During mock recall, traceability shall be performed for at least, one of the raw materials used in the batches identified for mock recall. Mock Recall shall be performed at least once for the longest distribution chain and whenever a distributor/marketing company changes. Records of such mock recalls should be maintained by the QA Head of the company.
Ans P4
Sir which guide line is supporting.
Please explain latest Process Validation theory.
I want to learn mechanism of all qc instrument,i mean how can any instrument work . by the way this clip was nice for learning purpose . Thanku very much
Did you skip step 5 in FMEA? Somehow I got lost in my notes.
Kindly write the reference guideline name
Super sir
It was a complicated topic but You explained it very clearly, thankyou so much❤️
Good information
94
We have to submitt stability data of exhibit batch or pilot batch???
Good topic Next change control
Nice explanation and superb
Excellent
PARA-IV certification
Liechtenstein Norway Iceland
Too nice content...
Thanks for sharing
Ans. : Iceland leitchstein and Norway
Super
Answer is Iceland ,Norway, Liechtenstein
Please explain variations and review of artworks
Briefly explained
1
Very nice
Inform your WhatsApp
Good explanation
What is EMR of 180 days ? EMR full form ?
Good job!
Excellent 👌
A
Kindly make video on OAI,VAI,NAI.
Great
Nice
Awesome
Thanks for clear Information Ans is Iceland..lichenstein...norway
Sustained release is not predetermined
X axis time and y axis drug plasma conc
Very good madam
Iceland, Liechtenstein, Norway