- 46
- 71 560
Hema Sharma
India
Приєднався 28 чер 2020
A pharmaceutical discussion group, refers to a group of pharmaceutical students and professionals. This includes a regular basis to update the participants on activities, regulations, and practices related to pharmaceutical processes and current regulatory requirements.
A motivations and innovative process of thinking can change the complications of pharmaceuticals requirements to a easy and effective process. A healthy and continuous learning process with easy understanding help to improve business and skill growth through knowledge sharing and implementation process.
Kindly give support , subscribe and share this channel with your friends.
A motivations and innovative process of thinking can change the complications of pharmaceuticals requirements to a easy and effective process. A healthy and continuous learning process with easy understanding help to improve business and skill growth through knowledge sharing and implementation process.
Kindly give support , subscribe and share this channel with your friends.
GAMP 5 "Chapter 3Life Cycle Approach"
A life cycle approach entails defining and performing activities in a systematic way from conception, understanding
the requirements, through development, release, and operational use, to system retirement.
GAMP 5 2nd Edition_Chapter 1: ua-cam.com/video/6FNzVI0hqBI/v-deo.html
GAMP 5 2nd Edition_Chapter 2: ua-cam.com/video/A5ThmA8cKBE/v-deo.html
the requirements, through development, release, and operational use, to system retirement.
GAMP 5 2nd Edition_Chapter 1: ua-cam.com/video/6FNzVI0hqBI/v-deo.html
GAMP 5 2nd Edition_Chapter 2: ua-cam.com/video/A5ThmA8cKBE/v-deo.html
Переглядів: 260
Відео
GAMP 5 2nd Edition_Chapter 2
Переглядів 43614 днів тому
GAMP 5 (Good Automated Manufacturing Practice) is a set of guidelines and best practices for automated systems in the pharmaceutical industry, developed by the International Society for Pharmaceutical Engineering (ISPE). The guidelines are intended to ensure that automated systems used in manufacturing, laboratory, and other regulated environments are reliable, fit for purpose, and compliant wi...
What is GAMP 5 2nd Edition
Переглядів 46721 день тому
GAMP 5 (Good Automated Manufacturing Practice) is a set of guidelines and best practices for automated systems in the pharmaceutical industry, developed by the International Society for Pharmaceutical Engineering (ISPE). The guidelines are intended to ensure that automated systems used in manufacturing, laboratory, and other regulated environments are reliable, fit for purpose, and compliant wi...
What is the Risk and Benefit of AI in Pharmaceutical Development
Переглядів 1152 місяці тому
Artificial Intelligence (AI) refers to the ability of algorithms encoded in technology to learn from data so that they can perform automated tasks without explicit programming of every step by a human.
What is the Role of AI in Pharmaceutical Development
Переглядів 1464 місяці тому
Present-day use of AI in the pharmaceutical sector is not the first use of computational approaches for this purpose. Computing has played a critical role for decades: computer-aided drug design dates to the 1970s , and, in the early 1980s, the “next industrial revolution” was proclaimed, with pharmaceuticals designed solely by computers . Computational approaches are also routinely used, for e...
Journey of Mr. Bhaskar Napte I #PharmaGrowthHub #Collab I Fe.Mr.Bhaskar Napte
Переглядів 2396 місяців тому
This Video is related to Conversation with Mr. Bhaskar Napte .
What is Supplier Activities in GxP Computerized Systems as per GAMP
Переглядів 2456 місяців тому
Supplier Activities in GxP Computerized Systems can not avoid . This video is related to Supplier Good Practice as per GAMP. Initial Risk Management :ua-cam.com/video/DA8GS0MN5Zg/v-deo.htmlsi=lRN2D2gCbS5A-L1U Agile in CSv: ua-cam.com/video/JU70v3MQEdo/v-deo.htmlsi=ufiZhN-IPD4eT14_ Software Vendor Audit :ua-cam.com/video/RGKLjPvxkIE/v-deo.htmlsi=OQzsihYUyU0N_kYr
What is Initial Risk Assessment in Computer System Validation
Переглядів 9857 місяців тому
This video describes the bullet points for requirement of Initial Risk Assessment in Computer System Validation. Thanks and regards Hema Sharma
What is Quality Intelligence in Pharmaceutical Industry.
Переглядів 1609 місяців тому
Dear Team, Quality Intelligence is a holistic approach that integrates data, analytics, and insights to drive continuous improvement in product quality within the pharmaceutical industry. It goes beyond traditional quality management by leveraging advanced technologies and data-driven methodologies. Thanks Hema Sharma
User Requirement Specification
Переглядів 36211 місяців тому
URS is a planning document that specifies what the software or system needs to do. It is written from the point of view of the end user and does not need to be technical or complicated.
User Requirement Specification (URS) in CSV
Переглядів 1,2 тис.Рік тому
User Requirements Specification (URS) is a crucial document in Computer System Validation (CSV), as it defines the functional and non-functional requirements of the software system that you need to meet your business objectives. The basic document for any CSV activities is URS. For any query please write on hemasharma.abc@gmail.com. You can watch minimum requirement of documents on ua-cam.com/v...
What is Agile in CSV
Переглядів 725Рік тому
When Agile comes to computer system validation (CSV), the Agile methodology can be applied to streamline the validation process and enhance efficiency.
How to prepare SOP of CSV
Переглядів 787Рік тому
The Computer system validation is very common in pharmaceutical industry. The basis documnt is SOP that describe our vision for handling the electronic and computer system validation and assurance.
What is Electronic Data Integirity(eDI)?
Переглядів 391Рік тому
The data integrity is one of the most important part of our compliance process. The strong principles and process related to integrity of data gives a confidence level up. The level of compliance decided the costumers or regulators satisfaction level. So the growth related to financial and moral values both, depends on data integrity process of organization. Please watch this video till end to ...
Concept Paper on the revision of Annex 11 Part 2/2
Переглядів 218Рік тому
The concept paper gives a valuable comment on current annex 11. All the practical issues and practices are summarized here. Please go through the video and try to understand the next level of compliance in regulated market. In this video we just try to understand the requirements. For part 1/2 refer to ua-cam.com/video/JQT9FkujNME/v-deo.html
What is Concept Paper on the revision of Annex 11
Переглядів 455Рік тому
What is Concept Paper on the revision of Annex 11
Audit preparation for Computer System Validation
Переглядів 669Рік тому
Audit preparation for Computer System Validation
Why "Risk Assessment" is required in Computer system validation (Learn with some warning letters)
Переглядів 834Рік тому
Why "Risk Assessment" is required in Computer system validation (Learn with some warning letters)
What is Risk in Computer system validation ( Explain with Example)
Переглядів 1,5 тис.Рік тому
What is Risk in Computer system validation ( Explain with Example)
What is the Risk in Computer system validation
Переглядів 6 тис.2 роки тому
What is the Risk in Computer system validation
Computer system validation "minimum requirement of documents "
Переглядів 1,4 тис.2 роки тому
Computer system validation "minimum requirement of documents "
What is Continued process verification (CPV) ?
Переглядів 2,7 тис.2 роки тому
What is Continued process verification (CPV) ?
GOOD PRACTICES FOR DATA MANAGMENT Part A
Переглядів 2332 роки тому
GOOD PRACTICES FOR DATA MANAGMENT Part A
Analytical Balance in pharmaceutical industry
Переглядів 7113 роки тому
Analytical Balance in pharmaceutical industry
It is very sightfull session mam.
Insightful information thanks ma'am
Good efforts
Super mam thankful video😊
Thanks Mam for sharing the knowledge
thanks a lot it was perfect
Madam your presentation is very good. But please explain in English, it will useful for all. Thank you
Data is the lack of uniformity. Data carries information but data in itself is not information.
Very good explanation mam🎉
ua-cam.com/video/moa0Zjh7RPY/v-deo.html
Nicely explained
Nice
Mam please give a ppt of cpv
Very good explaination , Thanks 👍
Thanks
Difference between mechanical, automatic and electronic type
Hello madam, hope you are doing well. Let me know that in repeatability there is a statement that if SD is less than 0.41d, then we should use 0.41 x least count of balance. So in which unit we have to take value of d. In g or mg ?
g
thank you Madam
You are most welcome
Nc
I want WHo insepction and approved my factory
How can i help me please tell me
WHO insepction requirement
Please tell WHO requirments for pharmaceutical sterial area
Why it is not good can anyone tell me I don't know so I'm asking
examples k sath explaination chahiye tha mam...thanx
Mam good evening,please tell to me how should i connect you, your explanation is simply super
Hema it's helpful......thanks. . .
Good job
Is there a good scope for CSV in pharma?
We don't understand. Pls elaborate in practical way
Sure pls write query on hemasharma.abc@gmail.com answer elaborate with example shall be Reply
What type of Tests shall be done in Agile Methodology? For example in Type V Model, We are performing following tests like: Server & Workstation Hardware Configuration, Password Policy, Audit Trail, Privileges Matrix Verification, Business Requirement Verification etc. Similar to this, please elaborate on tests to done in Agile Methodology for CSV
@@arijitdasgupta903 the agile methodology is related to a log term validation plan. like eQMS,LIMS etc. the software consist many parts like eQMS ,consist of Incident,deviation,change control, OOS ,market compliant etc. The agile methodology is related to that first develop one segment (like Change control), test ,comments with user and cross functional team, improve and than proceed to all requirements of CSV. after that second one (Like deviation).
@@HemaSharma thank you for providing the reply Based upon this, it can be concluded that agile methodology is applied to those enterprise software having multiple types of user requirements For example, in eQMS, where all QMS events are required to be configured Validation approach would be same like in Conventional CSV, only there should be step wise implementation and integration of each user requirements like C.C, then OOS, then Deviation etc. If I am correct as per your suggestion, then please provide a feedback for it
Hi madam Please provide your email I'd madam.
hemasharma.abc@gmail.com
Kindly make a video of water system qualification, validation and it's guidelines
What is a Configured Function please help in understanding the concept of Configuration please.
Madam could you make a video on RTM? If possible with respect to csv
Sure
Very nice presentation can you please prepare presentation on data integrity guidelines
Can you please explain about gap analysis also about csv
Nice madam
Thnx. it was really a nice session 👍
Good explanation madam
Good explanation madam thankyou, What is gxp and non gxp in computer system validation what exactly and what basis it is considered please explain madam
Please explain in English
Madam please give ur number i m trying to change my job from pharma industry to csv
Good work mam.. Tanq for sharing valuable information..
Madam thanks for the video,Please do with English subtitles with auto generated
This should be in English or atleast titles must be given ???? Else your heading must be in stated (only for hindi) I don't know what are you talking about...
U will get in English too
@@HemaSharma anyway I appreciate your efforts Hema
Thank you madam...
Great. Nicely explained
Very nice