Open Forum for Group Discussion
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This document provides an open forum for group discussion, comments, and Q&A on quality by design (QbD) approaches for pharmaceutical manufacturing. It poses 12 yes or no questions about key aspects of QbD, including whether a design space or real time release testing is required, whether all parameter interactions must be studied, and whether a site change invalidates a design space. The forum is intended to facilitate an exciting discussion on the regulatory acceptance of traditional versus QbD approaches.
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Q1: Vanderbilt is going to build a new dormitory and dining hall. The building will be a LEED Certified and high performing building, and the goals are both LEED Gold and Energy Star certifications. The campus architect has asked you to recommend a delivery method for this project. Which project delivery method would you recommend? Why?
Answer:
I would personally recommend the IPD method (The Integrated Project Delivery) For the LEED certification to reach its absolute in both LEED Gold and Energy Star Certification for Vanderbilt University build. The IPD is the transforming of the construction industry. More constructors are willing to adopt this method because there is a less chance of facing the risks in traditional projects. In IPD method everyone is involved like the owner, architect, constructor, engineer and sub constructor’s involvement of all members at every stage of the project as working together at every phase gives an opportunity to every member to make a part or contribute their skills, ideas, and knowledge. Comment by Kaveh Alagheh Bandhosseini: Bad grammar.
Break it down to two sentences. And why personally?
Be objective:
IPD is the best choice … It would help the project reach its absolute …
Comment by Kaveh Alagheh Bandhosseini: Why Caps?
Comment by Kaveh Alagheh Bandhosseini: Transformation?
Also it could be past tense because it has already happened
Comment by Kaveh Alagheh Bandhosseini: Different distribution of risk. Comment by Kaveh Alagheh Bandhosseini: From the owner to architect etc. everybody is involved in every stage and has a chance to contribute …(change the structure).
The reason for me choosing this (IPD) method is because of the following reasons:
· Certification by (Energy Star). This method will show the amount of energy consumed, and it will provide the building to be more a green building to the campus, with less energy consumption and less money spent in the future. Comment by Kaveh Alagheh Bandhosseini: I don’t think they have anything to do with each other directly.
With IPD you can come up with more efficient energy-conservation strategies early on and that helps both with leed and energy star
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· If all the members of the project meet daily and discuss the project, then there will be no any delay in the project. IPD method gives an equal amount of work to all the team members whereas in other traditional methods to force the constructors and sub constructors for work and they take the high risk Comment by Kaveh Alagheh Bandhosseini: They can cooperate and be aligned. They can focus on synergies and tradeoffs.
I don’t think this part is correct. Comment by Kaveh Alagheh Bandhosseini: No probably one charrette and a few meetings but not daily.
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IPD is the best choice … It would help the project reach its absolute …
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Also it could be past tense because it has already happened
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The reason for me choosing this (IPD) method is because of the following reasons:
· Certification by (Energy Star). This method will show the amount of energy consumed, and it will provide the building to be more a green building to the campus, with less energy consumption and less money spent in the future. Comment by Kaveh Alagheh Bandhosseini: I don’t think they have anything to do with each other directly.
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product owner/ customer and the development team.
Stay tuned for our upcoming webinars at https://www.synerzip.com/webinars/ that might be of your interest.
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The document discusses anti-thymocyte globulin (ATG), which is used for acute organ rejection. ATG is produced from rabbits that are inoculated with human T lymphocytes to trigger an antibody response. The antibodies produced in rabbits are then extracted, purified, and administered to patients to kill arrays of lymphocytes. Developing a process to characterize the target globulin and transferring knowledge will help establish protein production. Key challenges include maintaining clean environments and aseptic extraction, purification, and filling processes.
Centre for Quality Sciences-Information File-2024.pdf
The document discusses establishing the OR Centre for Quality Sciences to provide consulting services to the pharmaceutical and biologics industries regarding quality, regulatory affairs, innovation, and technology. It aims to engage subject matter experts to support academia, industry, and government. The Centre will focus on shifting from a compliance to a quality culture and aligning with new regulatory expectations in a changing technological landscape with advances in areas like artificial intelligence and data sciences. It will provide training, reviews, audits, and other services to support quality systems, documentation practices, regulatory submissions, clinical trials, and more.
A Tragic Resistance to Learn.pdf
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
230930.pdf
The document announces a training on demonstrating a quality management system during inspections to be held on September 30, 2023 in Kotri, Sindh. It will provide participants with techniques for showcasing compliance and procedures when regulatory audits occur. A list of attendees is included but not summarized for brevity.
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
The document provides tips for demonstrating a quality management system during an inspection. It advises being simple, clear, truthful, and confident when welcoming inspectors. Assign specific duties to staff and have flexibility. Listen fully to questions before responding, and don't argue - say you will look into issues. Practice mock inspections, recognize potential problems, and maintain your system daily.
Centre for Quality Sciences-2023
The document discusses the services provided by the Centre for Quality Sciences, which include designing new and upgrading existing pharmaceutical manufacturing facilities, conducting GMP audits and training, assisting with regulatory submissions, and providing consulting services regarding quality systems, data integrity, and compliance strategies. The Centre's vision is to shift the industry towards a quality culture through knowledge sharing and facilitating discussions to develop strategic roadmaps. It aims to help companies strengthen quality compliance and sustain their quality management systems in the changing regulatory landscape.
Track, Trace & Understand Science of Life from Real World Evidence.pdf
The document discusses biomarkers, which are measurable indicators of biological states or conditions. It describes biomarkers as tools that can help facilitate medical product development. The document outlines different types, categories, and descriptions of biomarkers. It discusses how biomarkers can be qualified and approved by regulatory agencies like the FDA for specific contexts of use. The document provides examples of biomarkers that have been used for various purposes, such as assessing disease diagnosis, treatment effectiveness, and safety. It also summarizes some biomarkers that have been qualified or considered for qualification by the FDA.
Confidence on Generics.pdf
1) The document discusses the evolution of ensuring drug quality from relying solely on testing to emphasizing proper manufacturing processes and controls.
2) It explains that without understanding the entire manufacturing process, one cannot say a drug is consistent in quality and purity or free of contamination.
3) Current good manufacturing practices (cGMP) help assure drug safety and efficacy by requiring facilities to control manufacturing operations through quality management systems and robust operating procedures.
Neurotoxicity & Neurodegenaration.pdf
The document discusses neurotoxicity and neurodegeneration in drug development. It notes that safety issues, especially related to the cardiovascular system and central nervous system, are among the most common reasons for drug development failure. Biomarkers for early detection of potential neurotoxicity could help improve success rates by facilitating safety screening earlier in the development process. The central nervous system is particularly vulnerable, as neurotoxicity is a frequent cause of failure in both pre-clinical and clinical phases of development.
Application of Data & AI in Pharma 4
Mr. Atiq ur Rahman has over 27 years of experience in pharmaceutical manufacturing and supply chain management. He has expertise in facility design, quality audits, and regulatory compliance. More recently, he has worked on data engineering, data acquisition, and applying data science concepts in pharmaceutical and other process industries. The presentation provides an overview of the industrial revolutions from Industry 1.0 to 5.0 and defines Pharma 4.0 as the convergence of people, systems, and data within a singular network powered by artificial intelligence. It discusses strategies for digital transformation and achieving digital maturity, including evaluating current technology needs and creating a roadmap with goals and timelines.
PICS-ICH
The document discusses the relationship between PIC/S and ICH and their roles in harmonizing GMP standards globally. PIC/S focuses specifically on GMP inspections and developing harmonized GMP standards and training inspectors. ICH focuses more broadly on safety, efficacy, quality and regulatory guidelines. Together they aim to promote reliance between regulatory authorities and open doors of trust through mutual recognition agreements and understanding of inspection systems. The document provides a comprehensive overview of their goals and collaboration to harmonize standards for patients worldwide.
Quality Affairs of Pharmaceuticals
The document discusses a presentation on quality issues observed by the FDA during inspections of pharmaceutical facilities in 2022. It notes the FDA observed deficiencies related to lack of written SOPs, insecure data, failure to investigate out of specification results, cleaning issues, and missing environmental monitoring programs. The document also presents a case study of a facility that had a significant media fill failure in November 2021 but did not initiate a recall until April 2022, exposing patients to risk. It describes poor aseptic techniques observed by FDA investigators during manufacturing operations.
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
The filling machine and HEPA filter located directly above the filling machine in the filling room were significantly discolored with an unknown substance. This indicates potential contamination issues that need to be investigated and addressed. Facilities should ensure machinery and equipment are properly cleaned and maintained to prevent contamination that could compromise product quality.
CQS Session - RO - 16 Oct 2022.pdf
The document discusses the pressure of real-world evidence on pharmaceutical regulatory science. It mentions the author's experience interacting with international regulatory agencies like the FDA, EU, Health Canada, and MHRA. It lists some references on topics like continuous manufacturing and real-time dissolution prediction. The document emphasizes that improving individual parts of a system will not improve the overall system, and that a systems approach to quality is needed.
GMP Session for Professional Development.pdf
This document provides information about an upcoming training session on Good Manufacturing Practices. The session will be held on October 16th in Karachi and will run from 9:00 am to 3:00 pm. It is aimed at pharmaceutical professionals with backgrounds in pharmacy, chemistry, microbiology and related fields. Experts from the US pharmaceutical industry will discuss advancements in manufacturing technology and emerging regulatory changes. The session will include tutorials, discussions, and Q&A to help participants better understand GMP requirements and ensure quality assurance. Participants will pay Rs. 10,000 or Rs. 5,000 depending on whether they are attending as part of their job. More details and contact information are provided.
Q & A - June - Sep 2022.pdf
This document contains questions and answers related to pharmaceutical quality and manufacturing. It discusses topics like clean hold time, dirty hold time, contamination control strategies, particles in injections, the differences between CMC, GMP, and continuous manufacturing. It also addresses questions about PIC/S, such as whether they issue membership, if inspections by one country are accepted by others, and that GMP certificates are issued by individual regulatory authorities rather than PIC/S.
Judging Science & Prior Knowledge Beyond the Line
This document discusses issues that may arise with generic drugs compared to innovator drugs. Bioequivalence studies only show equivalence at a single point in time and do not guarantee equivalence over the lifetime of the drug. Manufacturing the drug involves many variables like people, equipment, materials that could result in potency and dissolution differences compared to the innovator. The document provides data that showed increased hospitalization rates for certain generics compared to the innovator drug. It emphasizes the need for consistent quality manufacturing to ensure patient safety.
Maturing Drug Quality to Deliver Promise
The document discusses several topics related to improving drug quality including:
1) Evidence from clinical trials and real world use is key to determining drug effectiveness but quality can deteriorate after marketing authorization without a strong quality management system.
2) Errors must be eliminated through quality by design in development and operational excellence, and companies must continuously improve rather than just fixing problems.
3) Digital transformation, identifying critical quality attributes, and moving to more flexible and integrated quality systems will help address issues and improve patient outcomes.
PQRS 2022 - Education
This document appears to be a scanned receipt from a restaurant in New York City listing various food and drink items purchased, with a subtotal of $86.62 and total including tax of $97.45. The receipt details a variety of appetizers, entrees, drinks and desserts ordered for multiple guests.
4 - GMP June 2022 - CQS.pdf
This document discusses key elements of good manufacturing practices (GMP) for pharmaceutical manufacturing. It covers topics like building layout, equipment, utilities, documentation, materials, production processes, packaging, quality systems, facilities, laboratories and ensuring the safety, efficacy and quality of pharmaceutical products. The overall message is that GMP provides a foundation and framework to establish process and quality control, validate operations, continuously improve and ultimately ensure that pharmaceutical products meet their intended quality standards.
More from Obaid Ali / Roohi B. Obaid (20)
A Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological Products
Centre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
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在线办理(Murdoch毕业证书)莫道克大学毕业证电子版成绩单一模一样
学校原件一模一样【微信：741003700 】《(Murdoch毕业证书)莫道克大学毕业证电子版成绩单》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
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一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
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◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
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◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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在线办理(UVic毕业证书)维多利亚大学毕业证录取通知书一模一样
学校原件一模一样【微信：741003700 】《(UVic毕业证书)维多利亚大学毕业证》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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一比一原版(QU毕业证)皇后大学毕业证如何办理
QU本科学位证成绩单【微信95270640】《皇后大学毕业证书原版制作QU成绩单》【Q微信95270640】《仿制QU毕业证成绩单皇后大学学位证书pdf电子图》，A.为什么留学生需要操作留信认证?
留信认证全称全国留学生信息服务网认证,隶属于北京中科院。①留信认证门槛条件更低,费用更美丽,并且包过,完单周期短,效率高②留信认证虽然不能去国企,但是一般的公司都没有问题,因为国内很多公司连基本的留学生学历认证都不了解。这对于留学生来说,这就比自己光拿一个证书更有说服力,因为留学学历可以在留信网站上进行查询!
B.为什么我们提供的毕业证成绩单具有使用价值？
查询留服认证是国内鉴别留学生海外学历的唯一途径，但认证只是个体行为，不是所有留学生都操作，所以没有办理认证的留学生的学历在国内也是查询不到的，他们也仅仅只有一张文凭。所以这时候我们提供的和学校颁发的一模一样的毕业证成绩单，就有了使用价值。
实体公司，专业可靠，办理加拿大毕业证|办美国成绩单|做德国文凭学历认证|办新西兰学位证，办澳洲文凭认证，办留信网认证（网上可查，实体公司，专业可靠）铸就十年品质！信誉！实体公司！
文凭办理流程：
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2开始安排制作毕业证成绩单电子图；
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4毕业证成绩单电子版您确认信息无误之后安排制作成品；
5成品做好拍照或者视频给您确认；
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留信认证全称全国留学生信息服务网认证,隶属于北京中科院。①留信认证门槛条件更低,费用更美丽,并且包过,完单周期短,效率高②留信认证虽然不能去国企,但是一般的公司都没有问题,因为国内很多公司连基本的留学生学历认证都不了解。这对于留学生来说,这就比自己光拿一个证书更有说服力,因为留学学历可以在留信网站上进行查询!
B.为什么我们提供的毕业证成绩单具有使用价值？
查询留服认证是国内鉴别留学生海外学历的唯一途径但认证只是个体行为不是所有留学生都操作所以没有办理认证的留学生的学历在国内也是查询不到的他们也仅仅只有一张文凭。所以这时候我们提供的和学校颁发的一模一样的毕业证成绩单就有了使用价值。娃拒绝父亲送说往车上一躺就等着下车决无丢失的道理有手机在身联系也方便再说他都岁了还有大半车的小伙伴相伴他不怕在父亲千叮咛万嘱咐中山娃依依不舍地爬上车朝窗外不住地挥手别了父亲别了父亲的城别了我的暑假生活我的城市生活望着窗外挥舞的大手还有那张微驼的背一向坚强的山娃禁不住泪如雨下当我坐下来想写这封信时“感恩两字在我脑海中回旋很幸运我有这样的机会能将埋在心底深深的感激之情得以表达从婴儿的“哇哇坠地到哺育听
原版制作(澳洲WSU毕业证书)西悉尼大学毕业证文凭证书一模一样
学校原件一模一样【微信：741003700 】《(澳洲WSU毕业证书)西悉尼大学毕业证、文凭证书》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
The Management Guide: From Projects to Portfolio
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
原版制作(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单一模一样
学校原件一模一样【微信：741003700 】《(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
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- 1. Open Forum for Group Discussion, Comments & Q and A Roohi B. Obaid Civil Service Officer / Deputy Director, DRAP Member ISPE, PDA
- 2. Lets enter in an exciting discussion with visible participation
- 5. “Traditional Approach” is not accepted by the Regulatory Authority Yes No 1
- 6. Does application of QbD requires to have a Design Space (DS) or Real Time Release (RTR) Testing? Yes No 2
- 7. Is it required to study multivariate interactions of all the parameters to develop a design space? Yes No 3
- 8. Can Design Space simulate for Scale Up? Yes No 4
- 9. Does Site Change kill the outcome of Design Space for a product? Yes No 5
- 10. Validated & Proven Acceptable Ranges may be considered as a Design Space? Yes No 6
- 11. For an existing product, manufacturer needs to establish its design space? Yes No 7
- 12. Batch Release requirements in GMP are different for product manufactured with QbD &Traditional Approach? Yes No 8
- 13. Control Strategy & Design Space are similar and considered equal? Yes No 9
- 14. Product specifications for QbD & Minimal Approach are same? Yes No 10
- 15. Can Manufacturing be carried out outside the Control Strategy or Design Space? Yes No 11
- 16. Can Enhanced Approach be developed for a product that is manufactured under Traditional Approach? Yes No 12
- 17. Have a very good day and learning Email: cultureofcultivatingknowledge@gmail.com Facebook: Culture of Cultivating Knowledge Thank You