-
What are Regulations / Directives and Guidelines for Pharmaceutical Companies
This video is about What are Regulations / Directives and Guidelines for Pharmaceutical Companies
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
Let's Checkout Our Other Videos
List of ISO Guidelines : https://youtu.be/ZchLBHkoSrE
Clean room classification by ISO : https://youtu.be/id6UZVSvjLs
Validation of Autoclave and Qualification Part 1: https://youtu.be/3eO0VL_HF58
WFI Specifications : https://youtu.be/tKSFxGCAm8w
Steam Sterilization or Autoclaving Basic concepts Part 02 of 02: https://youtu.be/q_xt9UAX-YE
Pharma technical series interview questions and answers : https://youtu.be/r8NwXkLPOr4
Incident - https://youtu.be/l0EuPxyLMnU
Deviation Part 2 of 2 - https://youtu.be/hXZizwmpWd4
Dev...
published: 08 Apr 2021
-
💊 Pharma 101: Essential English Vocabulary for the Pharmaceutical Industry | Beginner's Guide
Welcome back to LearningEnglishPRO! Today, we have a special resource for beginners interested in the pharmaceutical industry. Dive into our 'Pharmaceutical Industry Wordlist' and embark on a journey to understand the key terms of this dynamic field. 🤩
📖 Here's a glimpse of what you'll discover:
Pharmaceutical Industry: The sector dedicated to researching, developing, and distributing medications. 💊
Medication: Various medical treatments, including pills, capsules, and syrups. 💉
Drug Discovery: The complex process of identifying and designing new medications. 🧪
Clinical Trials: Experiments to evaluate the safety and effectiveness of new drugs. 📊
Prescription Drug: Medications prescribed by a doctor. 📜
Over-the-Counter (OTC) Medication: Medications available without a prescription. 🏪...
published: 20 Oct 2023
-
USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation
'Data Integrity & Compliance with Drug CMGP' Question and Answers Guidance for Industry released in Dec 2018.
Explains the details about USFDA expectation on data integrity and ALCOA principles.
Give details about controls on electronic records, metadata, audit trail, static & dynamic data, data backup, data invalidation, computer system validation, shared logins, control of blank forms/ formats, audit trail review, audit trail frequency, electronic signatures, system suitability, reprocessing of chromatograms, training on data integrity, handling of data integrity problems.
Other Useful Presentations:
1. USFDA Guidance on Pharmaceutical Quality System https://youtu.be/KrE0eHD7GQg
2. ICH Q10 Guidance on Quality Systems https://youtu.be/39rplWqYz-0
3. Interview Question 'Tell Me about ...
published: 23 Sep 2021
-
Stability Study in Pharmaceutical Industry
This training video will make you understand about importance of the stability studies, trend of FDA citations since last 4 years, expectations of ICH guide , FDA and other GMP guides from stability studies. Further this video will explain you all important stages to understand about stability studies in pharmaceutical industry.LEARNINGPHARMACY.IN
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
published: 14 Jul 2020
-
Stability studies / Stability testing in pharmaceutical industry I Interview questions and answers
Stability studies / Stability testing in pharmaceutical industry I 30 Interview questions and answers
-----------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processi...
published: 08 Aug 2023
-
Cleaning Validation Regulatory Guidelines for the Pharmaceutical Industry
About the Webinar
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry. Included in the review will be the guide to inspection of cleaning validation from the FDA, as well as ICH-Guidelines Q7A and Q9 and the ASTM E3106-18 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation. Further, the guidance documents from ISPE – Cleaning Validation Lifecycle – Applications, Methods and Controls and the Pharmaceutical Inspection Co-Operation Scheme document PIC/S PI 006-3 as well as Ann...
published: 29 Jan 2021
-
Risk assessment in Pharmaceutical industry l Interview questions
Risk assessment in Pharmaceutical industry l Interview questions
------------------------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processing - Injectable processin...
published: 12 Apr 2023
-
An Introduction to the Pharmaceutical Industry A Beginner’s Guide
https://educolifesciences.com/product/introduction-to-cell-and-gene-therapies-a-beginners-guide/
An Introduction to Cell and Gene Therapies: A Beginner’s Guide | Training Course
We interviewed the course leader, John Faulkes, of the Educo Life Sciences on-demand e-learning course: An Introduction to the Pharmaceutical Industry: A Beginner’s Guide. We ask john to provide us with a summary of the course, who it is aimed at and how the course is taught. #educolifesciences #pharmaceuticals #intro
To learn more about the course and register click here
published: 23 Jan 2023
-
A Practical Pharmacy Guide to the Controlled Substance Act– 1.0 CE – Live Webinar on 03/05/24
Today’s live webinar is: A Practical Pharmacy Guide to the Controlled Substance Act by Alex Evans, PharmD, MBA
Follow these 3 simple steps to get CE Credit for your healthcare license renewal:
(1) SIGN UP - If you are already an AchieveCE member or have purchased a package containing this course, there is no additional charge for it. If you are not yet an AchieveCE member, you can purchase it for $25 and register here.
(2) WATCH THE VIDEO - Watch when it goes live to receive 1.0 hour of live CE credit or any other time to receive home study/enduring credit.
(3) ENTER YOUR CODE - At the end of this course, a 4-digit code will be provided. Click on your webinar course's "Attendance Confirmation" section and provide the code to receive CE renewal credit.
+WHO CAN GET CE RENEWAL CRE...
published: 06 Mar 2024
-
Inside the Pharmaceutical Manufacturing Process
In this video, we take a quick look into the world of pharmaceutical manufacturing. From the initial research and development phase to the final product, we explore every step of the process and provide a comprehensive look at how drugs are made. You'll learn about the different types of manufacturing facilities, the equipment and technology used, and the strict regulations that govern the industry. We'll also discuss the challenges and opportunities facing pharmaceutical manufacturers today, and what the future of the industry might look like. Whether you're a student, a healthcare professional, or simply curious about how your medications are made, this video is a must-watch. So sit back, relax, and join us for a fascinating journey into the world of pharmaceutical manufacturing.
published: 18 May 2023
5:34
What are Regulations / Directives and Guidelines for Pharmaceutical Companies
This video is about What are Regulations / Directives and Guidelines for Pharmaceutical Companies
Visit our website for more stuffs like guidelines, jobs, vaca...
This video is about What are Regulations / Directives and Guidelines for Pharmaceutical Companies
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
Let's Checkout Our Other Videos
List of ISO Guidelines : https://youtu.be/ZchLBHkoSrE
Clean room classification by ISO : https://youtu.be/id6UZVSvjLs
Validation of Autoclave and Qualification Part 1: https://youtu.be/3eO0VL_HF58
WFI Specifications : https://youtu.be/tKSFxGCAm8w
Steam Sterilization or Autoclaving Basic concepts Part 02 of 02: https://youtu.be/q_xt9UAX-YE
Pharma technical series interview questions and answers : https://youtu.be/r8NwXkLPOr4
Incident - https://youtu.be/l0EuPxyLMnU
Deviation Part 2 of 2 - https://youtu.be/hXZizwmpWd4
Deviation Part 1 of 2 -https://youtu.be/QKPku2hfkR0
Types of Thermocouples - https://youtu.be/hWnKkTklqGY
GMP History - https://youtu.be/_jh4dkMlPS8
GMP Vs cGMP - https://youtu.be/TG3bEni1CiM
Types of Validation - https://youtu.be/gHznNXTEHpc
Trick to remember 21 CFR - https://youtu.be/XQ2P-ghNMnw
Concept of ALCOA or Data integrity - https://youtu.be/RZiHltO9i1I
Concept of ALCOA or Data integrity - https://youtu.be/T4ykUGyvmHc
APQR - https://youtu.be/1ndy-_5CH9U
CAPA - https://youtu.be/bARe_itz-Ps
Tablet manufacturing process - https://youtu.be/INKMQJrcfWk
What are Regulations /Directives?
Ø Pharmaceutical regulations are defined as “the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information”.
Ø A Regulation takes a previous recommendation or guideline and makes it a requirement for legal operation. A regulation originates in an agency with either governmental or official authority and has the power of law.
What are Guidelines?
Ø A Guideline is a statement of advice or instruction pertaining to practice.
Ø Guidelines are departmental documents that are used to interpret legislation and/or regulation. Although they may be derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.
#PharmaRegulations
#PharmaGuidelines
#PharmaGyan
Hello, Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
https://wn.com/What_Are_Regulations_Directives_And_Guidelines_For_Pharmaceutical_Companies
This video is about What are Regulations / Directives and Guidelines for Pharmaceutical Companies
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
Let's Checkout Our Other Videos
List of ISO Guidelines : https://youtu.be/ZchLBHkoSrE
Clean room classification by ISO : https://youtu.be/id6UZVSvjLs
Validation of Autoclave and Qualification Part 1: https://youtu.be/3eO0VL_HF58
WFI Specifications : https://youtu.be/tKSFxGCAm8w
Steam Sterilization or Autoclaving Basic concepts Part 02 of 02: https://youtu.be/q_xt9UAX-YE
Pharma technical series interview questions and answers : https://youtu.be/r8NwXkLPOr4
Incident - https://youtu.be/l0EuPxyLMnU
Deviation Part 2 of 2 - https://youtu.be/hXZizwmpWd4
Deviation Part 1 of 2 -https://youtu.be/QKPku2hfkR0
Types of Thermocouples - https://youtu.be/hWnKkTklqGY
GMP History - https://youtu.be/_jh4dkMlPS8
GMP Vs cGMP - https://youtu.be/TG3bEni1CiM
Types of Validation - https://youtu.be/gHznNXTEHpc
Trick to remember 21 CFR - https://youtu.be/XQ2P-ghNMnw
Concept of ALCOA or Data integrity - https://youtu.be/RZiHltO9i1I
Concept of ALCOA or Data integrity - https://youtu.be/T4ykUGyvmHc
APQR - https://youtu.be/1ndy-_5CH9U
CAPA - https://youtu.be/bARe_itz-Ps
Tablet manufacturing process - https://youtu.be/INKMQJrcfWk
What are Regulations /Directives?
Ø Pharmaceutical regulations are defined as “the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information”.
Ø A Regulation takes a previous recommendation or guideline and makes it a requirement for legal operation. A regulation originates in an agency with either governmental or official authority and has the power of law.
What are Guidelines?
Ø A Guideline is a statement of advice or instruction pertaining to practice.
Ø Guidelines are departmental documents that are used to interpret legislation and/or regulation. Although they may be derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.
#PharmaRegulations
#PharmaGuidelines
#PharmaGyan
Hello, Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
- published: 08 Apr 2021
- views: 12665
6:31
💊 Pharma 101: Essential English Vocabulary for the Pharmaceutical Industry | Beginner's Guide
Welcome back to LearningEnglishPRO! Today, we have a special resource for beginners interested in the pharmaceutical industry. Dive into our 'Pharmaceutical Ind...
Welcome back to LearningEnglishPRO! Today, we have a special resource for beginners interested in the pharmaceutical industry. Dive into our 'Pharmaceutical Industry Wordlist' and embark on a journey to understand the key terms of this dynamic field. 🤩
📖 Here's a glimpse of what you'll discover:
Pharmaceutical Industry: The sector dedicated to researching, developing, and distributing medications. 💊
Medication: Various medical treatments, including pills, capsules, and syrups. 💉
Drug Discovery: The complex process of identifying and designing new medications. 🧪
Clinical Trials: Experiments to evaluate the safety and effectiveness of new drugs. 📊
Prescription Drug: Medications prescribed by a doctor. 📜
Over-the-Counter (OTC) Medication: Medications available without a prescription. 🏪
Vaccine: Substances stimulating the immune system against diseases. 💪
FDA (U.S.) / MHRA (UK): Regulatory authorities for medication safety. 🇺🇸🇬🇧
Pharmaceutical Company: Entities that research, develop, and manufacture medications. 🏭
Generic Drug: Cost-effective alternatives to brand-name meds. 💰
Biotechnology: Using biological systems for drug development. 🧫
Clinical Data: Data from trials assessing drug effectiveness. 📈
Side Effects: Unintended reactions from medication use. 😬
Placebo: Inert substances used as controls in clinical trials. 🤷
Pharmacovigilance: Ensuring drug safety and effectiveness. 🧐
This video is your ideal primer to the pharmaceutical world, providing foundational knowledge in simple, easy-to-understand English.
If you find this video helpful, hit the like button, and don't forget to subscribe for more educational content. Together, let's demystify the world of healthcare! 🌍💉
#PharmaceuticalIndustry #MedicalEnglish #Wordlist #LearningEnglish #HealthcareVocabulary #MedicalVocabulary #PharmaBeginners #DrugDiscovery #ClinicalTrials #PrescriptionMeds #VaccineEducation #FDAandMHRA #PharmaCompanies #GenericMeds #BiotechnologyExplained #ClinicalDataAnalysis #UnderstandingSideEffects #PlaceboControl #Pharmacovigilance #HealthcareEnglish
https://wn.com/💊_Pharma_101_Essential_English_Vocabulary_For_The_Pharmaceutical_Industry_|_Beginner's_Guide
Welcome back to LearningEnglishPRO! Today, we have a special resource for beginners interested in the pharmaceutical industry. Dive into our 'Pharmaceutical Industry Wordlist' and embark on a journey to understand the key terms of this dynamic field. 🤩
📖 Here's a glimpse of what you'll discover:
Pharmaceutical Industry: The sector dedicated to researching, developing, and distributing medications. 💊
Medication: Various medical treatments, including pills, capsules, and syrups. 💉
Drug Discovery: The complex process of identifying and designing new medications. 🧪
Clinical Trials: Experiments to evaluate the safety and effectiveness of new drugs. 📊
Prescription Drug: Medications prescribed by a doctor. 📜
Over-the-Counter (OTC) Medication: Medications available without a prescription. 🏪
Vaccine: Substances stimulating the immune system against diseases. 💪
FDA (U.S.) / MHRA (UK): Regulatory authorities for medication safety. 🇺🇸🇬🇧
Pharmaceutical Company: Entities that research, develop, and manufacture medications. 🏭
Generic Drug: Cost-effective alternatives to brand-name meds. 💰
Biotechnology: Using biological systems for drug development. 🧫
Clinical Data: Data from trials assessing drug effectiveness. 📈
Side Effects: Unintended reactions from medication use. 😬
Placebo: Inert substances used as controls in clinical trials. 🤷
Pharmacovigilance: Ensuring drug safety and effectiveness. 🧐
This video is your ideal primer to the pharmaceutical world, providing foundational knowledge in simple, easy-to-understand English.
If you find this video helpful, hit the like button, and don't forget to subscribe for more educational content. Together, let's demystify the world of healthcare! 🌍💉
#PharmaceuticalIndustry #MedicalEnglish #Wordlist #LearningEnglish #HealthcareVocabulary #MedicalVocabulary #PharmaBeginners #DrugDiscovery #ClinicalTrials #PrescriptionMeds #VaccineEducation #FDAandMHRA #PharmaCompanies #GenericMeds #BiotechnologyExplained #ClinicalDataAnalysis #UnderstandingSideEffects #PlaceboControl #Pharmacovigilance #HealthcareEnglish
- published: 20 Oct 2023
- views: 1905
19:06
USFDA Guidance for Data Integrity | USFDA Guidelines for Pharmaceutical | Easy Explanation
'Data Integrity & Compliance with Drug CMGP' Question and Answers Guidance for Industry released in Dec 2018.
Explains the details about USFDA expectation on d...
'Data Integrity & Compliance with Drug CMGP' Question and Answers Guidance for Industry released in Dec 2018.
Explains the details about USFDA expectation on data integrity and ALCOA principles.
Give details about controls on electronic records, metadata, audit trail, static & dynamic data, data backup, data invalidation, computer system validation, shared logins, control of blank forms/ formats, audit trail review, audit trail frequency, electronic signatures, system suitability, reprocessing of chromatograms, training on data integrity, handling of data integrity problems.
Other Useful Presentations:
1. USFDA Guidance on Pharmaceutical Quality System https://youtu.be/KrE0eHD7GQg
2. ICH Q10 Guidance on Quality Systems https://youtu.be/39rplWqYz-0
3. Interview Question 'Tell Me about yourself' https://youtu.be/WZrsu4vrUgo
4. 5 Step formula for interview preparation: https://youtu.be/6-Vsb-J1jWA
5. Interview Dont's, things you should not talk in interview: https://youtu.be/aSc9OBkpyzY
About the channel:
The channel has been developed with view of sharing information on Pharmaceutical Guidelines & Guidance..
Kindly subscribe to channel at: https://www.youtube.com/channel/UCis3Rsw8ev1d68OC1prwiNQ/
https://wn.com/Usfda_Guidance_For_Data_Integrity_|_Usfda_Guidelines_For_Pharmaceutical_|_Easy_Explanation
'Data Integrity & Compliance with Drug CMGP' Question and Answers Guidance for Industry released in Dec 2018.
Explains the details about USFDA expectation on data integrity and ALCOA principles.
Give details about controls on electronic records, metadata, audit trail, static & dynamic data, data backup, data invalidation, computer system validation, shared logins, control of blank forms/ formats, audit trail review, audit trail frequency, electronic signatures, system suitability, reprocessing of chromatograms, training on data integrity, handling of data integrity problems.
Other Useful Presentations:
1. USFDA Guidance on Pharmaceutical Quality System https://youtu.be/KrE0eHD7GQg
2. ICH Q10 Guidance on Quality Systems https://youtu.be/39rplWqYz-0
3. Interview Question 'Tell Me about yourself' https://youtu.be/WZrsu4vrUgo
4. 5 Step formula for interview preparation: https://youtu.be/6-Vsb-J1jWA
5. Interview Dont's, things you should not talk in interview: https://youtu.be/aSc9OBkpyzY
About the channel:
The channel has been developed with view of sharing information on Pharmaceutical Guidelines & Guidance..
Kindly subscribe to channel at: https://www.youtube.com/channel/UCis3Rsw8ev1d68OC1prwiNQ/
- published: 23 Sep 2021
- views: 3843
10:12
Stability Study in Pharmaceutical Industry
This training video will make you understand about importance of the stability studies, trend of FDA citations since last 4 years, expectations of ICH guide , F...
This training video will make you understand about importance of the stability studies, trend of FDA citations since last 4 years, expectations of ICH guide , FDA and other GMP guides from stability studies. Further this video will explain you all important stages to understand about stability studies in pharmaceutical industry.LEARNINGPHARMACY.IN
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
https://wn.com/Stability_Study_In_Pharmaceutical_Industry
This training video will make you understand about importance of the stability studies, trend of FDA citations since last 4 years, expectations of ICH guide , FDA and other GMP guides from stability studies. Further this video will explain you all important stages to understand about stability studies in pharmaceutical industry.LEARNINGPHARMACY.IN
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
- published: 14 Jul 2020
- views: 37026
13:01
Stability studies / Stability testing in pharmaceutical industry I Interview questions and answers
Stability studies / Stability testing in pharmaceutical industry I 30 Interview questions and answers
---------------------------------------------------------...
Stability studies / Stability testing in pharmaceutical industry I 30 Interview questions and answers
-----------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f
-----------------------------------------------------------------------------------------------
Questions covered:
Q. What is the purpose of stability studies in the pharmaceutical industry?
Q. What are the different stability zones for drug products?
Q. How are stability testing time points determined?
Q. What are the recommended storage conditions for stability studies?
Q. What are the key parameters monitored during stability studies?
Q. What is the difference between real-time and accelerated stability studies?
Q. What is the significance of the Arrhenius equation in stability studies?
Q. How do you determine the shelf-life of a drug product from stability data?
Q. What is the purpose of stress testing in stability studies?
Q. How are stability data used in the drug approval process?
Q. What is the role of stability indicating methods in stability studies?
Q. What are the acceptance criteria for stability studies?
Q. How do you handle photostability testing in stability studies?
Q. What is the impact of temperature excursions on stability studies?
Q. How do you establish a retest period for drug substances in stability studies?
Q. What is the role of statistical analysis in stability studies?
Q. How do stability studies account for container closure systems?
Q. What are the requirements for stability data storage and recordkeeping?
Q. How are stability studies impacted by scale-up and post-approval changes?
Q. What is the purpose of the Bracketing and Matrixing design in stability studies?
Q. How do you determine the frequency of stability testing for a drug product?
Q. What are the implications of stability data exception or deviation in stability studies?
Q. How is the photostability of a drug product assessed in stability studies?
Q. What is the role of stability studies in post-marketing surveillance??
Q. What are the four major product degradation types ?
Q. What are the implications of stability data non-compliance during regulatory submissions?
Q. How do you establish a dissolution specification in stability studies?
Q. What is the role of stability studies in post-approval change management?
Q. How are stability studies affected by variations in regional climatic conditions?
Q. Which Guideline are commonly referred for stability studies in pharmaceutical industry ?
-----------------------------------------------------------------------------------------------
Keywords to find this video:
stability study in pharmaceutial industry,stability study,stability study of pharmaceutical products,stability testing,stability study as per ich,stability studies,who guide for stability study,stability testing for pharmaceutical products,data integrity in pharmaceutical industry,stability study ich guideline,free learning on stability study,pharmaceutical industry (industry),stability testing for pharmaceutical products in hindi
-----------------------------------------------------------------------------------------------
Copyright disclaimer:
“Any illegal reproduction of this content will result in immediate legal action.”
https://wn.com/Stability_Studies_Stability_Testing_In_Pharmaceutical_Industry_I_Interview_Questions_And_Answers
Stability studies / Stability testing in pharmaceutical industry I 30 Interview questions and answers
-----------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f
-----------------------------------------------------------------------------------------------
Questions covered:
Q. What is the purpose of stability studies in the pharmaceutical industry?
Q. What are the different stability zones for drug products?
Q. How are stability testing time points determined?
Q. What are the recommended storage conditions for stability studies?
Q. What are the key parameters monitored during stability studies?
Q. What is the difference between real-time and accelerated stability studies?
Q. What is the significance of the Arrhenius equation in stability studies?
Q. How do you determine the shelf-life of a drug product from stability data?
Q. What is the purpose of stress testing in stability studies?
Q. How are stability data used in the drug approval process?
Q. What is the role of stability indicating methods in stability studies?
Q. What are the acceptance criteria for stability studies?
Q. How do you handle photostability testing in stability studies?
Q. What is the impact of temperature excursions on stability studies?
Q. How do you establish a retest period for drug substances in stability studies?
Q. What is the role of statistical analysis in stability studies?
Q. How do stability studies account for container closure systems?
Q. What are the requirements for stability data storage and recordkeeping?
Q. How are stability studies impacted by scale-up and post-approval changes?
Q. What is the purpose of the Bracketing and Matrixing design in stability studies?
Q. How do you determine the frequency of stability testing for a drug product?
Q. What are the implications of stability data exception or deviation in stability studies?
Q. How is the photostability of a drug product assessed in stability studies?
Q. What is the role of stability studies in post-marketing surveillance??
Q. What are the four major product degradation types ?
Q. What are the implications of stability data non-compliance during regulatory submissions?
Q. How do you establish a dissolution specification in stability studies?
Q. What is the role of stability studies in post-approval change management?
Q. How are stability studies affected by variations in regional climatic conditions?
Q. Which Guideline are commonly referred for stability studies in pharmaceutical industry ?
-----------------------------------------------------------------------------------------------
Keywords to find this video:
stability study in pharmaceutial industry,stability study,stability study of pharmaceutical products,stability testing,stability study as per ich,stability studies,who guide for stability study,stability testing for pharmaceutical products,data integrity in pharmaceutical industry,stability study ich guideline,free learning on stability study,pharmaceutical industry (industry),stability testing for pharmaceutical products in hindi
-----------------------------------------------------------------------------------------------
Copyright disclaimer:
“Any illegal reproduction of this content will result in immediate legal action.”
- published: 08 Aug 2023
- views: 8514
1:23:57
Cleaning Validation Regulatory Guidelines for the Pharmaceutical Industry
About the Webinar
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all ...
About the Webinar
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry. Included in the review will be the guide to inspection of cleaning validation from the FDA, as well as ICH-Guidelines Q7A and Q9 and the ASTM E3106-18 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation. Further, the guidance documents from ISPE – Cleaning Validation Lifecycle – Applications, Methods and Controls and the Pharmaceutical Inspection Co-Operation Scheme document PIC/S PI 006-3 as well as Annex 15 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use will be discussed. The main objective of this presentation is to enable understanding of the regulatory landscape and the detailed requirements from regulatory guidance documents that relate to the risk-based cleaning validation approach
About Thomas Altman : Thomas is a cleaning chemistry, cleaning process, cleaning validation and regulatory compliance subject matter expert. He is an expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is experienced in addressing regulatory inspection findings related to cleaning processes – and with implementing CAPA plans to prevent re-occurrence. Thomas has developed more than 1500 cleaning programs/ recommendations for pharmaceutical and personal care industries. Thomas contributed significantly to the ASTM E55 WK15778 Cleaning Process Development and Validation standard and published related articles as a co-author in “Pharmaceutical Engineering” as well as “Pharmaceutical Online” and “Biotechnology Online”. Prior to joining Ecolab, Thomas worked in the pharmaceutical and food industries.
https://wn.com/Cleaning_Validation_Regulatory_Guidelines_For_The_Pharmaceutical_Industry
About the Webinar
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry. Included in the review will be the guide to inspection of cleaning validation from the FDA, as well as ICH-Guidelines Q7A and Q9 and the ASTM E3106-18 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation. Further, the guidance documents from ISPE – Cleaning Validation Lifecycle – Applications, Methods and Controls and the Pharmaceutical Inspection Co-Operation Scheme document PIC/S PI 006-3 as well as Annex 15 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use will be discussed. The main objective of this presentation is to enable understanding of the regulatory landscape and the detailed requirements from regulatory guidance documents that relate to the risk-based cleaning validation approach
About Thomas Altman : Thomas is a cleaning chemistry, cleaning process, cleaning validation and regulatory compliance subject matter expert. He is an expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is experienced in addressing regulatory inspection findings related to cleaning processes – and with implementing CAPA plans to prevent re-occurrence. Thomas has developed more than 1500 cleaning programs/ recommendations for pharmaceutical and personal care industries. Thomas contributed significantly to the ASTM E55 WK15778 Cleaning Process Development and Validation standard and published related articles as a co-author in “Pharmaceutical Engineering” as well as “Pharmaceutical Online” and “Biotechnology Online”. Prior to joining Ecolab, Thomas worked in the pharmaceutical and food industries.
- published: 29 Jan 2021
- views: 39355
8:28
Risk assessment in Pharmaceutical industry l Interview questions
Risk assessment in Pharmaceutical industry l Interview questions
-----------------------------------------------------------------------------------------------...
Risk assessment in Pharmaceutical industry l Interview questions
------------------------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f
------------------------------------------------------------------------------------------------------------
Questions covered :
Q : Which guidelines are used for performing risk assessment in Pharmaceutical industry?
Q. Which are the three fundamental Questions asked during risk assessment ?
Q.: What is definition of ‘Risk’ as per ICH Q9 ?
Q. What is purpose of doing risk assessment ?
Q. Which are the systematic ways to identify what might go wrong ?
Q.: What is typical Quality Risk management process ?
Q.: What is procedure for initiating risk assessment ?
Q. What is severity, probability and detection ?
Q.: Which questions needs to be focused during risk control ?
Q.: How Quality Risk Management can be used for change control process?
Q. What is principle of quality Risk management ?
Q. What is Risk review ?
Q. What are the steps for Risk assessment ?
Q. How the severity raking is given ?
Q. How the Probability ranking is given ?
Q. How the Detection ranking is given ?
Q. What is RPN rating ?
Q.: Can severity will get reduced after mitigation plan implementation ?
Q.: When we should do risk assessment ?
Q. What is Risk communication ?
------------------------------------------------------------------------------------------------------------
Keywords to find this video :
risk assessment in pharmaceutical industry,risk assessment,pharmaceutical industry,risk management in pharmaceutical industry,quality risk management in pharmaceutical industry,quality risk assessment in pharmaceutical industry,risk assessment in pharmaceutical industries,risk assessment document pharmaceutical industry,data integrity in pharmaceutical industry,change control in pharmaceutical industry,pharmaceuticals,quality risk assessment in pharma company
------------------------------------------------------------------------------------------------------------
Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.”
https://wn.com/Risk_Assessment_In_Pharmaceutical_Industry_L_Interview_Questions
Risk assessment in Pharmaceutical industry l Interview questions
------------------------------------------------------------------------------------------------------------
Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f
------------------------------------------------------------------------------------------------------------
Questions covered :
Q : Which guidelines are used for performing risk assessment in Pharmaceutical industry?
Q. Which are the three fundamental Questions asked during risk assessment ?
Q.: What is definition of ‘Risk’ as per ICH Q9 ?
Q. What is purpose of doing risk assessment ?
Q. Which are the systematic ways to identify what might go wrong ?
Q.: What is typical Quality Risk management process ?
Q.: What is procedure for initiating risk assessment ?
Q. What is severity, probability and detection ?
Q.: Which questions needs to be focused during risk control ?
Q.: How Quality Risk Management can be used for change control process?
Q. What is principle of quality Risk management ?
Q. What is Risk review ?
Q. What are the steps for Risk assessment ?
Q. How the severity raking is given ?
Q. How the Probability ranking is given ?
Q. How the Detection ranking is given ?
Q. What is RPN rating ?
Q.: Can severity will get reduced after mitigation plan implementation ?
Q.: When we should do risk assessment ?
Q. What is Risk communication ?
------------------------------------------------------------------------------------------------------------
Keywords to find this video :
risk assessment in pharmaceutical industry,risk assessment,pharmaceutical industry,risk management in pharmaceutical industry,quality risk management in pharmaceutical industry,quality risk assessment in pharmaceutical industry,risk assessment in pharmaceutical industries,risk assessment document pharmaceutical industry,data integrity in pharmaceutical industry,change control in pharmaceutical industry,pharmaceuticals,quality risk assessment in pharma company
------------------------------------------------------------------------------------------------------------
Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.”
- published: 12 Apr 2023
- views: 9597
3:46
An Introduction to the Pharmaceutical Industry A Beginner’s Guide
https://educolifesciences.com/product/introduction-to-cell-and-gene-therapies-a-beginners-guide/
An Introduction to Cell and Gene Therapies: A Beginner’s Guide...
https://educolifesciences.com/product/introduction-to-cell-and-gene-therapies-a-beginners-guide/
An Introduction to Cell and Gene Therapies: A Beginner’s Guide | Training Course
We interviewed the course leader, John Faulkes, of the Educo Life Sciences on-demand e-learning course: An Introduction to the Pharmaceutical Industry: A Beginner’s Guide. We ask john to provide us with a summary of the course, who it is aimed at and how the course is taught. #educolifesciences #pharmaceuticals #intro
To learn more about the course and register click here
https://wn.com/An_Introduction_To_The_Pharmaceutical_Industry_A_Beginner’S_Guide
https://educolifesciences.com/product/introduction-to-cell-and-gene-therapies-a-beginners-guide/
An Introduction to Cell and Gene Therapies: A Beginner’s Guide | Training Course
We interviewed the course leader, John Faulkes, of the Educo Life Sciences on-demand e-learning course: An Introduction to the Pharmaceutical Industry: A Beginner’s Guide. We ask john to provide us with a summary of the course, who it is aimed at and how the course is taught. #educolifesciences #pharmaceuticals #intro
To learn more about the course and register click here
- published: 23 Jan 2023
- views: 170
1:08:12
A Practical Pharmacy Guide to the Controlled Substance Act– 1.0 CE – Live Webinar on 03/05/24
Today’s live webinar is: A Practical Pharmacy Guide to the Controlled Substance Act by Alex Evans, PharmD, MBA
Follow these 3 simple steps to get CE Credit f...
Today’s live webinar is: A Practical Pharmacy Guide to the Controlled Substance Act by Alex Evans, PharmD, MBA
Follow these 3 simple steps to get CE Credit for your healthcare license renewal:
(1) SIGN UP - If you are already an AchieveCE member or have purchased a package containing this course, there is no additional charge for it. If you are not yet an AchieveCE member, you can purchase it for $25 and register here.
(2) WATCH THE VIDEO - Watch when it goes live to receive 1.0 hour of live CE credit or any other time to receive home study/enduring credit.
(3) ENTER YOUR CODE - At the end of this course, a 4-digit code will be provided. Click on your webinar course's "Attendance Confirmation" section and provide the code to receive CE renewal credit.
+WHO CAN GET CE RENEWAL CREDIT FOR THIS COURSE?
This course provides 1.0 contact hour of continuing education credit to healthcare professionals, specifically:
PHARMACY: Pharmacists and Pharmacy Technicians
+COURSE DESCRIPTION:
Pharmacy staff, regardless of practice setting, must access patient health information on a daily basis in order to perform their jobs. It is critical that they act in accordance with the law when interacting with and sharing patient protected health information, or they could face action from their employer or their law, and their employer could face fines and lose the trust of the public. In order to prevent a breach in privacy, the pharmacy staff must understand privacy laws.
This CE activity will provide in-depth coverage of healthcare privacy law, focusing on HIPAA and HITECH. It will provide a background and history of those laws, review who must comply and what the requirements are, and use case studies and examples to discuss appropriate and inappropriate disclosure of PHI. At the conclusion of this activity, learners will be confident in handling PHI in accordance with federal law and with appropriately reporting breaches of PHI. Pharmacists and pharmacy technicians will appreciate requirements of businesses that handle PHI.
+LEARNING OBJECTIVES:
At the conclusion of this continuing education activity, the participant will be able to:
-Define PHI and understand the requirements for handling PHI, including business and individual responsibilities for use and disclosure of PHI.
-Appreciate the safeguards businesses who handle PHI must take to prevent inappropriate PHI disclosure.
-Describe the requirements of the Breach Notification Rule and when, and to who, must be notified of inappropriately disclosed PHI.
Follow us on our social media accounts!
Facebook: https://www.facebook.com/achieveceonline
Instagram: https://www.instagram.com/achieveceon...
Linkedin: https://www.linkedin.com/company/achi...
#LiveCE #Pharmacy #Pharmacist #Dentistry #Nurses #RN #LPN #APRN #HCP #OTs #OTAs #CEU #CE #LicenseRenewal #AchieveCE
https://wn.com/A_Practical_Pharmacy_Guide_To_The_Controlled_Substance_Act–_1.0_Ce_–_Live_Webinar_On_03_05_24
Today’s live webinar is: A Practical Pharmacy Guide to the Controlled Substance Act by Alex Evans, PharmD, MBA
Follow these 3 simple steps to get CE Credit for your healthcare license renewal:
(1) SIGN UP - If you are already an AchieveCE member or have purchased a package containing this course, there is no additional charge for it. If you are not yet an AchieveCE member, you can purchase it for $25 and register here.
(2) WATCH THE VIDEO - Watch when it goes live to receive 1.0 hour of live CE credit or any other time to receive home study/enduring credit.
(3) ENTER YOUR CODE - At the end of this course, a 4-digit code will be provided. Click on your webinar course's "Attendance Confirmation" section and provide the code to receive CE renewal credit.
+WHO CAN GET CE RENEWAL CREDIT FOR THIS COURSE?
This course provides 1.0 contact hour of continuing education credit to healthcare professionals, specifically:
PHARMACY: Pharmacists and Pharmacy Technicians
+COURSE DESCRIPTION:
Pharmacy staff, regardless of practice setting, must access patient health information on a daily basis in order to perform their jobs. It is critical that they act in accordance with the law when interacting with and sharing patient protected health information, or they could face action from their employer or their law, and their employer could face fines and lose the trust of the public. In order to prevent a breach in privacy, the pharmacy staff must understand privacy laws.
This CE activity will provide in-depth coverage of healthcare privacy law, focusing on HIPAA and HITECH. It will provide a background and history of those laws, review who must comply and what the requirements are, and use case studies and examples to discuss appropriate and inappropriate disclosure of PHI. At the conclusion of this activity, learners will be confident in handling PHI in accordance with federal law and with appropriately reporting breaches of PHI. Pharmacists and pharmacy technicians will appreciate requirements of businesses that handle PHI.
+LEARNING OBJECTIVES:
At the conclusion of this continuing education activity, the participant will be able to:
-Define PHI and understand the requirements for handling PHI, including business and individual responsibilities for use and disclosure of PHI.
-Appreciate the safeguards businesses who handle PHI must take to prevent inappropriate PHI disclosure.
-Describe the requirements of the Breach Notification Rule and when, and to who, must be notified of inappropriately disclosed PHI.
Follow us on our social media accounts!
Facebook: https://www.facebook.com/achieveceonline
Instagram: https://www.instagram.com/achieveceon...
Linkedin: https://www.linkedin.com/company/achi...
#LiveCE #Pharmacy #Pharmacist #Dentistry #Nurses #RN #LPN #APRN #HCP #OTs #OTAs #CEU #CE #LicenseRenewal #AchieveCE
- published: 06 Mar 2024
- views: 26
1:14
Inside the Pharmaceutical Manufacturing Process
In this video, we take a quick look into the world of pharmaceutical manufacturing. From the initial research and development phase to the final product, we exp...
In this video, we take a quick look into the world of pharmaceutical manufacturing. From the initial research and development phase to the final product, we explore every step of the process and provide a comprehensive look at how drugs are made. You'll learn about the different types of manufacturing facilities, the equipment and technology used, and the strict regulations that govern the industry. We'll also discuss the challenges and opportunities facing pharmaceutical manufacturers today, and what the future of the industry might look like. Whether you're a student, a healthcare professional, or simply curious about how your medications are made, this video is a must-watch. So sit back, relax, and join us for a fascinating journey into the world of pharmaceutical manufacturing.
https://wn.com/Inside_The_Pharmaceutical_Manufacturing_Process
In this video, we take a quick look into the world of pharmaceutical manufacturing. From the initial research and development phase to the final product, we explore every step of the process and provide a comprehensive look at how drugs are made. You'll learn about the different types of manufacturing facilities, the equipment and technology used, and the strict regulations that govern the industry. We'll also discuss the challenges and opportunities facing pharmaceutical manufacturers today, and what the future of the industry might look like. Whether you're a student, a healthcare professional, or simply curious about how your medications are made, this video is a must-watch. So sit back, relax, and join us for a fascinating journey into the world of pharmaceutical manufacturing.
- published: 18 May 2023
- views: 1558