https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
Audit training
Introduction in Registration
Introduction in QMS
Good Manufacturing Practices (GMP)
Good Distribution Practices (GDP)
Good Laboratorical Practices (GCP)
Introduction in Validation Basics
Acceptance Sampling
Design of Experiment (DoE)
Quality by Design (QbD)
GAMP5
Intro Serialisatie
Tech Transfer
ISO 13485 – Medical Device
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
This ppt consists of types of FDA inspection, and how to prepare for FDA inspection of pharmaceutical mfg site, and what to do before FDA inspection, During FDA inspection, and after FDA inspection.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
How Sirus, Building Services Management Company use EQMS by Qualsys. Here Pauline Sourdille explains all the different ways the team use EQMS for compliance and quality management.
https://qualsys.co.uk/case-studies/sirus/
More https://quality.eqms.co.uk/blog/introduction-to-apqp
New to the advanced product quality planning framework?
Don't despair. In this article, Mike Bendall, Business Mentor at Qualsys, explains APQP, provides a checklist for each APQP phase, and there is a link to download his APQP training course for beginners.
Full GDPR toolkit: https://quality.eqms.co.uk/gdpr-general-data-protection-regulation-eu-toolkit
This free online training presentation provides you with information about how to comply with the General Data Protection Regulation, managing breaches, engaging employees, key requirements and more.
Culture of quality workshop - Qualsys Training WorkshopQualsys Ltd
Establish and nurture a culture of quality within your organisation with this quality culture training.
More tools and resources at https://quality.eqms.co.uk/culture-of-quality-toolkit
The slides contain:
- How to sustain a culture of quality
- Culture of quality and continuous improvement
- Culture of quality vision statement
ISO 45001:2018 Health and Safety Management SoftwareQualsys Ltd
Health and safety survey findings - the key challenges
Transitioning from OHSAS 18001 to ISO 45001:2018
Implementing a health and safety management system
A look at 3 case study organisations
Technology recommendations for:
Capturing risk and incident data
Root cause analytics, Big Data, IoT and predictive scoring
A culture of wellbeing and safety
Integrating health and safety considerations into business change processes
Examples of how our software is used
Get your questions answered
https://quality.eqms.co.uk/health-and-safety-webinar
Lean six sigma explained: Beginners trainingQualsys Ltd
A free online introduction to Lean six sigma principles.
Includes lean six sigma tools, philosophy, disciplines, history overview of lean six sigma, applying DMAIC for complex decision making, using Qualsys EQMS software for Lean Six Sigma.
Best practice approach for PLM, Product Supply and SourcingQualsys Ltd
Buy-in presentation for PLM professionals who want an electronic management system. Download this presentation and use it for your own business case if you need better control over the products you supply, product sourcing and a more agile approach to product life cycle management. EQMS software can help capture data throughout the product lifecycle.
ISO 22301 leadership buy in presentationQualsys Ltd
ISO 22301 Leadership buy-in presentation. Demonstrate your leadership skills with this ISO 22301 business continuity management system leadership buy-in presentation. This explains why business continuity is essential, why follow ISO 22301 and the resources required to get your business continuity management system established.
How to Drive Engagement with Enterprise Compliance SoftwareQualsys Ltd
Rob Gibson is an experienced IT Systems Manager who has developed his career at facilities management and food service company Sodexo. Over the past four years, Rob has been instrumental in rolling out EQMS - an electronic quality and compliance management system. Sodexo use EQMS to manage document control, audits, incident logging and training records for many of their heavily-regulated sites. Rob has introduced and managed a number of initiatives to raise awareness of the system and engage its users. Rob and his team are now on an exciting journey to roll out EQMS worldwide. As Sodexo is one of the largest employers in the world, this is not without its challenges! In this presentation, Rob shares his journey, tips and advice for rolling out a global quality and compliance management software solution.
Preparing for GDPR: General Data Protection Regulation - Stakeholder Presenta...Qualsys Ltd
Preparing for the new General Data Protection Regulation? Here is a presentation to help you to engage your employees with their new information security requirements. In this ppt presentation, you will find out: why GDPR, steps to manage compliance, important information security facts and some of the key articles.
Embedding a culture of quality: ISO 9001:2015 FocusQualsys Ltd
What does an organisation with a mature culture of quality look like? In this ppt presentation, Richard Green, Former Head of Technical Services at CQI, explains what a culture of quality looks like, the essential building blocks and how to achieve this.
More information can be found: http://quality.eqms.co.uk/blog/6-critical-building-blocks-of-a-quality-culture
7 Step Guide To Successfully Managing a Change Project & Winning Stakeholders...Qualsys Ltd
70% of change management projects fail! 46% of senior managers agree that communication is the biggest issue.
From initial reluctance for people to do things differently, not understanding WHY a change is being implemented, denial of requirement for change, overcoming objections is unique to each project and each organisation, language barriers in global organisations and managing change roll-out across multiple sites.
Follow this 7 Step Guide to win stakeholders hearts and minds.
Watch the presentation: http://quality.eqms.co.uk/asset-equipment-management
In this slideshare:
1. An Introduction to Equipment Management: Why Business Equipment is Critical to your Business and The 7 Key Problems with Managing Business Equipment.
2. The Asset Register : Record Keeping – Compliance and a Basis for Effective Management, What and Where.
3. Maintenance and Calibration: Keeping Track of Safety: Staff – Customers – Partners – the Public.
4. The High Cost of Failure: Regulatory Non-Compliance and Human and Financial Costs.
5. Best Practice: Safe Operation, Smart Equipment and the Internet of Everything
Use this Slideshare for a best practice approach towards:
- asset register,
- preventive maintenance schedule management,
- maintenance repair and operations,
- maintenance program for equipment,
- heavy equipment maintenance,
- programmed maintenance,
- medical equipment management, industrial equipment maintenance, equipment safety, and facility maintenance management strategies are discussed detail.
More information: www.eqms.co.uk .
This survey takes the temperature of the Quality Industry 2016, identifying trends and listening to your opinions on the most pressing issues facing Quality. Never before have Quality professionals encountered such pressure in balancing and prioritising various organisational demands such as:
Hitting KPIs despite a lack of resource and tighter deadlines.
Identifying new opportunities for process improvement.
Complying to evolving Standards and regulations.
Aggregating data from a multitude of data sources.
As technology evolves alongside developing regulatory requirements, so does the role of the Quality professional. It’s time to ask, how do you compare with others in your industry?
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
effectively manage the convert Accpac to QuickBooks , with a particular focus on utilizing online accounting services to streamline the process.
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It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
Remote sensing and monitoring are changing the mining industry for the better. These are providing innovative solutions to long-standing challenges. Those related to exploration, extraction, and overall environmental management by mining technology companies Odisha. These technologies make use of satellite imaging, aerial photography and sensors to collect data that might be inaccessible or from hazardous locations. With the use of this technology, mining operations are becoming increasingly efficient. Let us gain more insight into the key aspects associated with remote sensing and monitoring when it comes to mining.
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As a business owner in Delaware, staying on top of your tax obligations is paramount, especially with the annual deadline for Delaware Franchise Tax looming on March 1. One such obligation is the annual Delaware Franchise Tax, which serves as a crucial requirement for maintaining your company’s legal standing within the state. While the prospect of handling tax matters may seem daunting, rest assured that the process can be straightforward with the right guidance. In this comprehensive guide, we’ll walk you through the steps of filing your Delaware Franchise Tax and provide insights to help you navigate the process effectively.
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As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
5. Quality is essential
• Can’t check the quality before buying or
trying
• Prescriber and patient must be confident no
harm is going to occur, and that the product
does what it says it does
• The right product is prescribed, at the right
strength
• Accurate labelling
• Free from contamination
• Correct packaging
• Product is fit for purpose
• Risks are understood and effectively treated
GxP in EQMS: www.qualsys.co.uk
6. GxP aids compliance with global regulations
• GxP regulations refer to underlying international pharmaceutical requirements such as those outlined in:
• US FD&C Act
• US PHS Act
• FDA regulations
• EU Directives
• Japanese regulations
• Other applicable national legislation / regulations:
• Good Manufacturing Practice (GMP)
• Good Clinical Practice (GCP)
• Good Distribution Practice (GDP)
• Good Quality Practice (GQP)
• Good Pharmacovigilance Practice (GVP)
• Medical Device Regulations (MedDev)
• Prescription Drug Marketing Act (PDMA)
7. Five Ps of GxP
People
• Have clear roles and responsibilities
• Follow all procedures
• Fully trained and assessed for the work
they do
Procedures
• Documented and recorded
• Cover all critical processes
• Ensure deviations are fully
investigated
and reported
Products
• Specifications for raw materials,
components, intermediate and finished
product
• Methods for manufacture and packing,
testing, sampling, status control,
stability testing and records
Premises and
equipment
• Designed to allow effective cleaning
and prevent cross-contamination
• Validated and calibrated, have
procedures, schedules and records
Processes
• Clearly defined, consistent and
documented
• Critical steps identified
• Any required changes must follow the
change control procedures
GxP with EQMS: www.qualsys.co.uk
8. Things can still go wrong…
1. Investigation of anomalies
2. Supplier and contractor Audit
3. Design and Maintenance of equipment
4. CAPA
5. Line Clearance and Segregation
6. Design and Maintenance of Facilities
7. Quality Management – Change control
8. Quality Management
9. Contamination – chemical / physical
9. Typical FDA findings:
• Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications,
whether or not the batch has already been distributed (21 CFR 211.192).
• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR
820.198(a).
• Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
• Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned
responsibilities. Training shall be documented, as required by 21 CFR 820.25(b).
10. Quality management challenges
Consistency
•Same standards
all the time
across the
business
Controls
•Good security,
documentation,
risk and data
management
Compliance
•Alignment of
regulated and
non-regulated
information,
transparency
and policy
control
12. Computerised systems
• Organisations are rapidly transforming
• Outsourcing, mergers and acquisitions and rationalise portfolios
• Regulatory fines are on the rise, legal exposure and loses in revenue without
effective risk management and information governance
• This has meant GxP organsiations have not been able to move their content
to the cloud as aggressively as they would like
• Many have legacy systems which are inflexible to user needs, time
consuming to maintain and validate and have inefficient silos between
regulated and unregulated information – slowing collaboration and innovation
13. Why businesses choose EQMS by Qualsys
• The EQMS suite is an integrated, easy-to-use
GxP process management software system
• Configurable applications address the challenges
of competing in a regulated market according to
GLP, GCP, GMP and GDP regulations.
• The EQMS suite connects applications for
automating, streamlining, and effectively
managing document control, change control,
training control, audits, CAPA, customer
complaints, and more.
• Unlike other companies, Qualsys provides a
thorough Validation Master Plan support service
GxP with EQMS: www.qualsys.co.uk
15. Quality management system implementation
• Multiple layers of security and governance technology
• Operational practices
• Compliance policies
• World-class implementation service
• Guided validation
• Experience and training implementing GxP systems, ISO 13485, ISO
17025, & more
17. Key considerations when choosing software
1.Ensuring the confidentiality,
integrity and availability of data
stored in the cloud
2.Controls are maintained
3.Re-validation is manageable
when there is a change
History is littered with examples of quality failures in the life science industry.
At best, the company recognises an issue before any patients are harmed.
At worst, it causes death, pain and suffering for patients.
Solutions are considered qualified when they can demonstrate the ability to fulfill GxP requirements. GxP regulations include pharmaceutical requirements, such as those outlined in the U.S. Food and Drug Administration CFR Title 21 Part 11, and EU GMP Annex 11.