Training Session on Good Manufacturing Practices of the 21st Century
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This document outlines areas for research to advance Good Manufacturing Practices in the 21st century. It discusses investigating and evaluating novel manufacturing methods and their impact on product failure rates and quality. It also addresses developing improved analytical methods to evaluate product quality using emerging technologies, and developing sensitive methods to detect and reduce microbial contamination. The overall goals are to enable development and evaluation of important manufacturing improvements, lower the cost of manufacturing, and improve the ability of regulatory agencies to ensure safety, quality and efficacy.
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Training Session on Good Manufacturing Practices of the 21st Century
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The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
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“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
Curriculum Vitae
The document is a curriculum vitae for Dr. Zakia Saeed, who has over 15 years of experience in pharmaceutical quality control, quality assurance, and regulatory affairs. She holds a PhD and MPhil in Pharmaceutical Chemistry from Karachi University. Her experience includes positions as Quality Control & Quality Assurance Manager at C.K.D Pharmaceuticals Pakistan and Senior Manager of Quality Assurance & Regulatory Affairs at Medisure Laboratories Pakistan, where she oversaw quality management, inspections, and regulatory compliance. She is skilled in methods validation, documentation, auditing, and ensuring compliance with cGMP standards.
Introduction qa, qc and tqm
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Introduction to pharma industry
This document provides an overview of the key departments and functions within the pharmaceutical industry. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. It also outlines the responsibilities of key personnel like heads of production and quality control, as well as the qualified person. The document emphasizes that effective quality management systems are important for product realization, process control, and continual improvement.
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This document announces a professional development session on the pharmaceuticals dashboard for 2021. It will discuss topics like uncertainty in quality, the future of manufacturing and regulations, and competitiveness with trade barriers. The session aims to help professionals mature their skills and align with emerging expectations. It will use tutorials, discussions, examples and case studies. Participant assessment will be confidential. The session facilitators have extensive regulatory experience in Pakistan and international agencies. It will be held on December 19th in Karachi with a small group size.
Achieving Quality and Compliance Excellence in Pharmaceuticals
This document provides an introduction to a master class guide on achieving quality and compliance excellence in pharmaceuticals. It contains contributions from various experts in the pharmaceutical industry on topics related to quality assurance, compliance, and regulatory affairs. The editor's goal is to help pharmaceutical professionals implement robust quality systems and ensure adherence to regulations. The book is intended to provide guidance on all aspects of quality and compliance for drug products and operations.
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The document provides an overview of quality control and quality assurance from international perspectives including the USA, WHO, ICH, and India. It discusses the key drug regulatory authorities around the world such as the USFDA, CDSCO in India, ICH, and WHO. The USFDA, CDSCO, and their roles and guidelines are explained in further detail. The International Conference on Harmonization (ICH) is introduced as a project that brings regulators and industry experts together to discuss registration of pharmaceuticals. The World Health Organization (WHO) is summarized as the directing and coordinating authority on international health issues.
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3) Tools used in QbD analytical method development like risk assessment, identification of critical quality attributes, method design, and qualification to ensure method performance.
Qbd1
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. The key elements of QbD include defining a Target Product Quality Profile, identifying critical quality attributes and critical process parameters, risk assessment, establishing a design space, and developing a control strategy. The objectives of QbD are to identify important product attributes leading to quality, determine attributes that impact product variability, and establish a design space to allow variability in material attributes.
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CV_Manoj_31.08.2016
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K M Suleman
Khan Muhammad is applying for a position in quality control at a pharmaceutical company. He has over 9 years of experience in quality control roles at various pharmaceutical companies in Pakistan. He holds an MSc in Chemistry and a BSc with honors. His current role is as a Senior Executive of Quality Control at PharmEvo Pvt Ltd, where he has worked since 2009. His responsibilities include analytical testing, method development and validation, instrument operation and calibration, and ensuring compliance with cGMP standards.
Concept of qa, qc, gmp 112070804010
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
Sharon Resume Management 14MAY15-1
Seventeen year career in quality assurance and quality control roles in the pharmaceutical industry, with nine years of management experience ensuring compliant product and process development, manufacturing, and testing. Experience includes creating quality guidelines, managing teams, and leading continuous improvement initiatives.
CV_Ruturaj
1) Ruturaj K Sutarsandhiya is seeking a challenging opportunity in pharmaceutical analytical development with a focus on method development, validation, and stability studies.
2) He has over 15 years of experience in method development, validation, and stability studies for drug products and substances. He has experience conducting in vitro bioequivalence studies.
3) His most recent role was as Manager I at Sun Pharmaceuticals, where he successfully completed over 150 method validations and was a key member of the organization.
Resume
Johnson Joseph is an experienced quality professional seeking a management position. He has over 10 years of experience in quality analysis and ensuring compliance with regulatory standards like US-FDA, WHO, and local authorities. He is skilled in quality operations like audits, validations, environmental monitoring, and handling regulatory approvals and licenses. His expertise includes microbiological testing, method development, process simulation, and instrument qualification.
SCIENTIFICALLY BASED QBD.pptx
SCIENTIFICALLY BASED QBD
NAME:PAWAN DHAMALA
SUB: CADD
TOPIC:SCIENTIFICALLY BASED QUALITY BY DESIGN(QBD)
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
RCWCV
Over 30 years of experience in the pharmaceutical industry including roles in research, manufacturing, quality assurance, and regulatory compliance. Expertise in FDA regulations and effective communication skills. Fluent in Mandarin Chinese. Seeking a consultant position applying extensive knowledge of CMC operations and drug development.
MD-Manager Nichols_Becky 2016
This document is a resume for Rebecca L. Nichols summarizing her experience and qualifications for managerial positions in pharmaceuticals, nutraceuticals, and related industries. She has over 20 years of experience leading teams and ensuring on-time project delivery through process improvements. Her expertise includes analytical method development and validation, quality control procedures, and facilitating regulatory filings. She has successfully managed laboratories, mergers, and method transfers between facilities.
CV
The document is a curriculum vitae for Dattatraya Raghunath More. It summarizes his qualifications and 15 years of experience in laboratory management, quality management, and health and safety. It details his roles at various pharmaceutical companies in India and the UAE, highlighting his skills in analytical equipment operation, method development and validation, quality auditing, and ensuring compliance with various standards like ISO 9001, ISO 14001, and ISO 17025.
Pharma Quality Metrics
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
Similar to Training Session on Good Manufacturing Practices of the 21st Century (20)
An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An Efficient Analytical Development Strategy for Rapid Development of Biophar...
An efficient analytical development strategy for rapid development of biophar...
An efficient analytical development strategy for rapid development of biophar...
Quality by design in analytical method developmentpptx
Quality by design in analytical method developmentpptx
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
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五：与学校颁发的相关证件1:1纸质尺寸制定（定期向各大院校毕业生购买最新版本毕,业证成绩单保证您拿到的是鲁昂大学内部最新版本毕业证成绩单微信95270640）
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。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
Credit-Management seminar for cooperative power point presentation
Credit-Management seminar for cooperative power point presentation
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
Resource-mobilization-guide-for-community-based-organizations1.pdf
resource mobilization guidebook for comminute based organizations
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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Training Session on Good Manufacturing Practices of the 21st Century
- 1. Connect to the Future from the Past (Part 4/4) Training Session by OR Centre for Quality Sciences Good Manufacturing Practices (GMP) of the 21st Century 04 April 2021, Hotel Marriott Karachi Obaid Ali & Roohi B. Obaid
- 2. Enable development & evaluation of important & improved manufacturing methods
- 4. Investigate the effect of continuous manufacturing on product 1 Examine technologies to determine how they impact product failure rates 2
- 5. Evaluate the role of excipients & complex dosage forms on product 3 Promote state of art manufacturing strategies, PAT, QbD & consistent quality 4
- 6. Develop new analytical methods
- 8. Investigate feasibility & value of using emerging & improved analytical technologies for evaluating product quality of pharmaceutical agents, and evaluate whether these technologies should replace existing methods For e.g. NMR, MS, NIR, Raman Spectroscopy 1
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- 10. Perform statistical research to support development & evaluation of new assay & tests needed to assure analytical methods give consistent reproducible results 3
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- 19. Thanks