Gdp how to manage documentation lifecycle
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Learn how to manage document cycle from preparation through final evaluation and get trained on the key documentation requirements.
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This document provides an introduction to internal audits, including defining what an internal audit is, who conducts and is audited, what documents are reviewed, how the audit process is planned and conducted, and how findings are reported. It describes internal auditors as competent professionals who independently audit processes by reviewing documents, conducting inspections and interviews to make objective assessments. It outlines what areas and documents are reviewed, how audit plans and schedules are developed, where audits take place, the audit process, and how findings are categorized and addressed.
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The document discusses the importance and principles of auditing quality management systems. It defines key audit terms and outlines the audit process, including planning, execution, reporting, and follow-up. Audits are necessary to ensure effectiveness of quality system implementation, evaluate performance, and drive continuous improvement. The audit process involves preparing an audit program and checklists, conducting opening and closing meetings, gathering objective evidence through observation and documentation review, and issuing corrective actions when nonconformities are found.
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The document discusses quality audits in the pharmaceutical industry. It defines a quality audit as an objective, systematic, independent and documented assessment of a company's quality system against given criteria. Audits are intended to provide unfiltered information to management, help minimize risk, and ensure the company remains in a state of control. The document emphasizes that audits should make quality systems compliant, effective and efficient. It provides tips for selecting qualified auditors, communicating results to management, and ensuring corrective actions are taken to continuously improve processes.
Auditing1
Auditing is an important part of quality assurance and quality management. It involves systematically and objectively evaluating processes, systems, or services against predefined standards to ensure compliance. The goals of auditing are to find any deviations from these standards, analyze their causes, and implement changes to improve performance and prevent issues from reoccurring. Auditing can be internal, conducted by an organization's own staff, or external, conducted by independent third parties. It follows a standard process of planning, data collection on site, analysis, reporting, and verifying that any necessary corrective actions were successfully implemented.
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Documentation
This document summarizes a laboratory quality control workshop that will take place from October 21-22, 2020. The workshop will cover good documentation practices, which are the foundation of a quality management system. Key topics that will be discussed include the essential documents required for a quality management system, the document control process and master list, how to properly complete laboratory records, and understanding documentation compliance in audits. The workshop will provide templates for standard operating procedures and master lists to demonstrate proper documentation structure and format.
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Pa2
ISO 9001:2000 sets out the criteria for gaining certification and operating according to the quality standard. It requires a quality policy statement from management linked to business goals and customer needs. It also requires processes to be mapped, monitored, measured and analyzed to ensure quality objectives are met. Issues must be dealt with through corrective and preventive actions and internal audits to continually improve the quality system.
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This document provides information on implementing a quality management system according to ISO 9000 standards. It outlines 14 steps for implementation:
1. Commitment from top management
2. Establishing an implementation team
3. Conducting awareness programs
4. Providing training
5. Conducting an initial status survey
6. Creating an implementation plan
7. Developing documentation
8. Controlling documents
9. Implementation
10. Internal quality audits
11. Management reviews
12. Pre-assessment audits
13. Certification and registration
14. Continual improvement
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1) It discusses auditor competence and responsibilities, such as being objective, ethical, and maintaining confidentiality.
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The document outlines the key aspects of implementing an ISO9001:2008 quality management system, including establishing a quality management committee, appointing a management representative and document controller, developing a quality manual with procedures, work instructions and forms, and a staged implementation process involving initial assessment and awareness training, documentation and implementation, and ultimately external audit and certification. The purpose of ISO9001:2008 is to increase business value through accountability, measurability, standardization, and effective management.
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Guide for the implementation of a Quality management
This document provides an overview of quality management systems and standards. It discusses ISO 9000 norms including ISO 9001, 9004, and 19011. It describes the requirements of an ISO 9001 quality management system including the purpose, standards, terms and definitions, management responsibilities, resource management, realization of services, measurement and improvement, and more. It also discusses implementing a quality management system including forming a work team, process mapping, staff training, audits, corrective actions, certification, and tools. Finally, it provides an example of quality assurance in education from Catalonia.
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This chapter discusses quality in Central Service operations. It defines quality as meeting established standards consistently to satisfy customer needs. Key aspects of a quality program include administrative indicators like policies and procedures, customer satisfaction indicators, and technical indicators. The chapter covers quality tools like Failure Mode and Effects Analysis and Root Cause Analysis. Common quality programs discussed are quality assurance, continuous quality improvement, total quality management, and standards. The chapter concludes with reviewing quality procedures in Central Service like following safety protocols and checking work.
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This document discusses information system audits. It defines an information system audit as testing the control activities of an IT infrastructure to ensure it meets standards. The document outlines the stages of an information system audit including preliminary examination, detailed examination, conformance testing, evidence verification, and overall assessment. It also discusses who can conduct audits, including management, IT managers, specialists, and users. The document provides an overview of the IT audit process and principles as well as the outputs, which typically include an audit report detailing the scope, methodology, findings, and conclusions.
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The auditing process involves systematically obtaining and evaluating evidence to determine if assertions align with criteria, and communicating results. It examines a company's internal controls, accounting systems, and procedures. Assessing control risk evaluates how well controls prevent misstatements. High control risk requires extensive substantive testing, while low risk may allow reliance on controls with less substantive testing. Information technology can impact controls, audit trails, and the auditing process.
Eeoqms internal auditing
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This document provides an introduction to quality management system audits. It defines an audit as a systematic, independent and documented process for evaluating evidence objectively to determine if audit criteria are fulfilled. Audits are required by ISO 9001:2008 and help monitor/measure the management system, identify improvement opportunities, and promote continuous improvement. The benefits of auditing include increased awareness, reduced risk of failure, and achievement of planned results. The document then describes the types of audits, principles for auditors and audits, the PDCA methodology, elements of quality management system audits, typical audit activities from initiation to follow up, and techniques for collecting evidence and generating findings.
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This document discusses good documentation practices. It defines good documentation as accurately recording all activities so there is documented evidence of what was done. It emphasizes that documentation is essential for quality assurance and regulatory compliance. The document outlines standards for documentation including contemporaneous record keeping, approvals, signatures, revisions, retention, and review. It describes typical elements of a documentation system and different types of documents.
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The document provides guidance for internal auditors on ISO 9001:2015. It discusses planning an audit, conducting an opening and closing meeting, asking open-ended questions, documenting findings, and validating findings. The purpose of internal audits is to measure performance and determine conformance. Auditors should be prepared, conduct themselves professionally, and focus on continuous improvement opportunities.
Jean_Paul_Assam_Assam_-_Documentation.ppt
This document summarizes a laboratory quality control workshop that will take place from October 21-22, 2020. The workshop will cover good documentation practices, which are the foundation of a quality management system. Key topics that will be discussed include the essential documents required for a quality management system, the document control process and master list, how to properly complete laboratory records, and understanding documentation compliance in audits. The workshop will provide templates for standard operating procedures and master lists to demonstrate proper documentation structure and format.
Documentation
This document summarizes a laboratory quality control workshop that will take place from October 21-22, 2020. The workshop will cover good documentation practices, which are the foundation of a quality management system. Key topics that will be discussed include the essential documents required for a quality management system, the document control process and master list, how to properly complete laboratory records, and understanding documentation compliance in audits. The workshop will provide templates for standard operating procedures and master lists to demonstrate proper documentation structure and format.
Standards of Internal Audit
The document discusses planning and documentation standards for internal audits. It covers objectives of planning, factors affecting the planning process and scope, and the planning process itself which includes establishing the audit universe and objectives. It emphasizes obtaining appropriate audit evidence to draw reasonable conclusions and reviewing evidence obtained. Documentation standards are also outlined, including matters to be documented, identification of preparers and reviewers, and document retention policies.
Pa2
ISO 9001:2000 sets out the criteria for gaining certification and operating according to the quality standard. It requires a quality policy statement from management linked to business goals and customer needs. It also requires processes to be mapped, monitored, measured and analyzed to ensure quality objectives are met. Issues must be dealt with through corrective and preventive actions and internal audits to continually improve the quality system.
Implementing quality management system
This document provides information on implementing a quality management system according to ISO 9000 standards. It outlines 14 steps for implementation:
1. Commitment from top management
2. Establishing an implementation team
3. Conducting awareness programs
4. Providing training
5. Conducting an initial status survey
6. Creating an implementation plan
7. Developing documentation
8. Controlling documents
9. Implementation
10. Internal quality audits
11. Management reviews
12. Pre-assessment audits
13. Certification and registration
14. Continual improvement
It also discusses quality management tools like check sheets, control charts, and Pareto charts that can be used for implementation
Basic concepts of quality assurance
The document discusses various concepts related to quality assurance and auditing. It defines quality assurance and describes how evidence is used to ensure quality requirements are met. It also discusses different types of audits including internal, second party, and third party audits. The key components of structuring an audit program include planning audits, conducting audits, verifying findings, and following up on corrective actions. Audit reports should document objective findings and subjective judgements to evaluate performance. Product audits help estimate quality levels and effectiveness of inspections in determining conformance to specifications.
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Free trade zones
What is a Free Trade Zone?
A free trade zone (FTZ)is a designated area that eliminates traditional trade barriers, such as tariffs, some kind of taxes and fees and minimizes bureaucratic
regulations.
The goal of a free trade zone is to enhance global market presence of the Country or location by attracting new business and foreign investments.
Tax-free trade zones generate foreign exchange through exports, and create economic value added.
Free, foreign, and export processing zones all fall under the umbrella of being free trade zones. Because these terms are confusingly similar, they are often used
interchangeably.
Sec what you need to know
What is SEC?
The U.S. Securities and Exchange Commission (SEC) oversees the key participants in the securities world.
Concerned with promoting disclosure of important market information, maintaining fair dealing, and protecting against fraud.
Responsibilities include:
Interpret and enforce federal securities laws
Issue new rules and amend existing rules
Oversee inspection of securities firms, brokers, investment advisers and ratings agencies
Oversee private regulatory organizations in securities, accounting, auditing fields
Coordinate U.S. securities regulation with federal, state, and foreign authorities
SEC Organization:
Division of Corporate Finance:Reviews documents required to be filed with the Commission
Division of Trading: Assists in maintaining fair, orderly and efficient markets.
Division of Investment Management: Maintains oversight of America’s $26T investment management industry
Division of Enforcement: Recommends commencement of investigations of SEC law violations
Division of Economic and Risk Analysis: Integrates robust economic analysis and data analytics
Laws Governing SEC:
Securities Act of 1933
Securities Exchange Act of 1934
Trust Indenture Act of 1939
Investment Company Act of 1940
Investment Advisers Act of 1940
Sarbanes-Oxley Act of 2002
Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010
Jumpstart Our Business Startups Act of 2012
SEC Reports:
8k - A report of unscheduled material events or corporate changes at a company that could be of importance to the shareholders or SEC
10k - Comprehensive summary report of a company's performance. Submitted annually to the SEC
10Q - A comprehensive report of a company's performance that must be submitted quarterly by all public companies to SEC. In10-Q, firms are required to disclose relevant information regarding their financial position.
18K - Use to update the SEC and investors regarding the status of a domestically traded foreign security and its issuer.
20F - A form issued by the SEC that must be submitted by all "foreign private issuers" that have listed equity shares on exchanges in the U.S.
SEC Investigations:
Can be triggered in many ways
Investigation is not the same as prosecution
Investigations involve fact finding and are usually not public
During an investigation, neither the staff nor the Commission makes any determination of wrongdoing
Following investigation, SEC staff present findings to the Commission
Commission can authorize the staff to file a case in federal court or bring an administrative action.
Auditing your grc programs
What Constitutes a GRC Program?
Governance, risk and compliance or GRC programs are complex – an organization has to use its GRC program to address the regulatory requirements expected of, among
others, the following:
Enterprise Risk Management
COSO Internal Controls
Environmental Compliance (EPA rules)
Anti Trust
Anti Money Laundering
Anti Bribery/Corruption
Quality Management and Standards such as ISO 9000, 9001
Process Management such as Six Sigma
Anti Harassment
Human Capital
Whistle-blowing
HR Processes
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regulatory environment.
Internal audits of GRC programs allow management and the board to identify risks and areas that need strengthening and root out any non-compliance.
An audit can help evaluate the adequacy of the program’s design and effectiveness as well as new practices and technologies to be implemented.
Audits of the GRC program have to be carried out periodically – these should supplement an ongoing, daily evaluation of the effectiveness of the program, including
monitoring of controls and responses.
Internal Audit Process – The General Steps:
Define evaluation scope, objectives, and the type of evaluation.
Define the level and type of assurance
Identify the evaluation team and skills required.
Develop evaluation plan.
Perform design adequacy evaluation.
Perform operational effectiveness evaluation.
Communicate evaluation results and ensure follow-up to address issues.
Aml non bank finanacial institutions
This quick reference guide discusses the anti-money laundering requirements for non-bank financial institutions including for Money Services Business (MSB).
Workplace harrasment
The document defines harassment as unwelcome verbal or physical conduct based on protected characteristics that results in a tangible employment action or creates a hostile work environment. It states harassment can be committed by managers, coworkers, customers, vendors, and others, and can target victims, bystanders, or witnesses. The document provides examples of sexual harassment and advises reviewing anti-harassment policies, complying with anti-discrimination laws, knowing how to respond to issues, and reporting harassment immediately. It recommends online training resources on these topics.
Good documentation practices
This quick reference guide discusses key documentation requirements and tips to good documentation practices.
Information security threats
What is Information Security?
Information security means that the confidentiality, integrity and availability of information assets is maintained.
Confidentiality: This means that information is only used by people who are authorized to access it.
Integrity: It ensures that information remains intact and unaltered. Any changes to the information through malicious action, natural disaster, or even a simple innocent mistake are tracked.
Availability: This means that the information is accessible when authorized users need it.
Information Security Threats:
Most common types of information security threats are:
Theft of confidential information by hacking
System sabotage by hackers
Phishing and other social engineering attacks
Virus, spyware and malware
Social Media-the fraud threat
Theft of Confidential Information:
One of the major threat to information security is the theft of confidential data by hacking. This includes theft of employee information or theft of trade secrets and other intellectual property (IP).
Theft of Employee Information
Employee information includes credit card information, corporate credit card information, social security number , address, etc. It also includes theft of healthcare records as they contain personal information such date of birth, address, and name of relatives.
Theft of Trade Secrets and other Intellectual Property (IP)
Technology from various verticals including IT, aerospace, and telecommunications are constantly stolen by outsiders or insiders (industrial espionage). China is a growing offender as it continues to advance in technology relying on theft of international trade secrets and IP.
Piracy/copyright infringement.
Corporate business strategies including marketing strategies, product introduction strategies.
System Sabotage:
What is system sabotage?
Planting malware on networks of target organization and generating an enormous amount of transaction activity resulting in malfunction or crash of the system.
Who would perpetrate it?
System sabotage is usually committed by disgruntled ex-employees and by remote cyber-attackers for no particular reason.
The most sensational case of system sabotage: One of the recent examples is the sabotage of Sony PlayStation.
Phishing:
To obtain confidential data about individuals-customers, clients, employees or vendors that can be used to commit various types of identity fraud such as:
Opening bank accounts in victim’s name
Applying for loans in victim’s name
Applying for credit cards in victim’s name
Obtaining medical services in victims name (e-death)
Other kind of more sophisticated social engineering attacks include spear-phishing.
Spear-phishing targets specific individuals such as AP manger, controller, senior accountant to gain access to corporate bank accounts and transfer funds abroad.
Other threats include:
Smishing: Phishing via SMS (texting)
Vishing: Phishing via voice (phone)
Mobile hackin
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Equivariant neural networks and representation theory
Or: Beyond linear.
Abstract: Equivariant neural networks are neural networks that incorporate symmetries. The nonlinear activation functions in these networks result in interesting nonlinear equivariant maps between simple representations, and motivate the key player of this talk: piecewise linear representation theory.
Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
The binding of cosmological structures by massless topological defects
Assuming spherical symmetry and weak field, it is shown that if one solves the Poisson equation or the Einstein field
equations sourced by a topological defect, i.e. a singularity of a very specific form, the result is a localized gravitational
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Deep Software Variability and Frictionless Reproducibility
Deep Software Variability and Frictionless ReproducibilityUniversity of Rennes, INSA Rennes, Inria/IRISA, CNRS
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
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I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
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Cytokines and their role in immune regulation.pptx
This presentation covers the content and information on "Cytokines " and their role in immune regulation .
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Slides from talk:
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The debris of the ‘last major merger’ is dynamically young
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Inter-Society Networking Panel GRSS/MTT-S/CIS Panel Session: Promoting Connection and Cooperation
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hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills原版制作(carleton毕业证书)卡尔顿大学毕业证硕士文凭原版一模一样
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Current descriptions of immersive learning cases are often difficult or impossible to compare. This is due to a myriad of different options on what details to include, which aspects are relevant, and on the descriptive approaches employed. Also, these aspects often combine very specific details with more general guidelines or indicate intents and rationales without clarifying their implementation. In this paper we provide a method to describe immersive learning cases that is structured to enable comparisons, yet flexible enough to allow researchers and practitioners to decide which aspects to include. This method leverages a taxonomy that classifies educational aspects at three levels (uses, practices, and strategies) and then utilizes two frameworks, the Immersive Learning Brain and the Immersion Cube, to enable a structured description and interpretation of immersive learning cases. The method is then demonstrated on a published immersive learning case on training for wind turbine maintenance using virtual reality. Applying the method results in a structured artifact, the Immersive Learning Case Sheet, that tags the case with its proximal uses, practices, and strategies, and refines the free text case description to ensure that matching details are included. This contribution is thus a case description method in support of future comparative research of immersive learning cases. We then discuss how the resulting description and interpretation can be leveraged to change immersion learning cases, by enriching them (considering low-effort changes or additions) or innovating (exploring more challenging avenues of transformation). The method holds significant promise to support better-grounded research in immersive learning.
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Immersive Learning That Works: Research Grounding and Paths Forward
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
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With increasing population, people need to rely on packaged food stuffs. Packaging of food materials requires the preservation of food. There are various methods for the treatment of food to preserve them and irradiation treatment of food is one of them. It is the most common and the most harmless method for the food preservation as it does not alter the necessary micronutrients of food materials. Although irradiated food doesn’t cause any harm to the human health but still the quality assessment of food is required to provide consumers with necessary information about the food. ESR spectroscopy is the most sophisticated way to investigate the quality of the food and the free radicals induced during the processing of the food. ESR spin trapping technique is useful for the detection of highly unstable radicals in the food. The antioxidant capability of liquid food and beverages in mainly performed by spin trapping technique.
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Gdp how to manage documentation lifecycle
- 2. Documentation is : A set of documents (written or graphical procedures, manuals, policies , instructions, specifications) and records (recorded information of performed activity). A process that involves the systematic interaction of people, events and documents to create the records. Quality can not be assured in a regulated industry without good documentation practices.
- 3. ISO 9001:2008 specifically requires the organization to have documented procedures for the following six activities: Control of documents Control of records Internal audit Control of nonconforming product Corrective action Preventive action Additional needed documents are: Quality policy Quality objectives Quality manual
- 5. How to draft procedures to avoid errors? clear instructions written with sufficient details well understandable well defined responsibilities easy to implement
- 6. What can be reviewed and evaluated when checking individual documents? the information that is stated the information that is not stated requirements legal/regulatory issues safety/risk analysis the rationale of document
- 7. Documentation usually signed by the following functions: Author/owner Head of relevant department Reviewer Approver Head of quality/Regulatory department Document Control
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- 9. Want to learn more about GDP, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: How to Comply with GDP Requirements? Good Documentation Practices for GXPs Introduction to FDA Good Documentation Practices An Easy to Understand Guide to Good Documentation Practices Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances