This document provides an overview of challenges facing the life sciences industry and discusses validation requirements for computer systems. It contains the following information:
- The pharmaceutical, medical device, and biotechnology industries face issues like loss of revenue from generics, high costs to develop new drugs, and new regulations. Computer validation is important in these regulated industries.
- FDA validation requirements are defined as demonstrating through documented evidence that a system consistently operates according to predetermined specifications. Validation ensures quality, objectivity, and that developers cannot check their own work.
- A validation toolkit is presented that follows GAMP 5 guidelines and parallels an established validation methodology. It contains templates, scripts, and tools to help customers efficiently validate computer systems in a
QualiTest offers a holistic testing approach which provides an end-to-end test at a fraction of the cost compared to current market approaches.
QualiTest understands the challenges and risks involved in ICD-10 transformation across the healthcare spectrum: providers, payers, clearinghouses, and vendors. As the world’s second-largest independent pure play QA and testing solution partner, QualiTest provides comprehensive end-to-end services for ICD-10 testing to all entities in the healthcare industry.
http://www.qualitestgroup.com
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
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This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Regulatory 101 for Medical Device Start UpsEMMAIntl
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In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
QualiTest offers a holistic testing approach which provides an end-to-end test at a fraction of the cost compared to current market approaches.
QualiTest understands the challenges and risks involved in ICD-10 transformation across the healthcare spectrum: providers, payers, clearinghouses, and vendors. As the world’s second-largest independent pure play QA and testing solution partner, QualiTest provides comprehensive end-to-end services for ICD-10 testing to all entities in the healthcare industry.
http://www.qualitestgroup.com
Design Controls: Building Objective Evidence and Process Architecture to Mee...April Bright
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This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Regulatory 101 for Medical Device Start UpsEMMAIntl
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In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
Self-Audits – Crucial for Your Medical PracticeJessica Parker
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Auditing is important to evaluate the physician processes to make sure their compliance plan is operating correctly and to identify any inappropriate documentation, coding, and/or billing practices. One of the most important reasons for auditing is to identify any potential areas of concern that could put the physician or practice at risk for audits.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Automated System Validation in FloridaAndre Butler
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The ADB Consulting services are providing a different type of services like as: - Automation System Validation & more. An Automated system validation must be carried out for manufacturing processes to be flawless and a success. Validation of an automatic system helps ensure.
A presentation delivered June 4, 2009 describing the impact of the economic crisis on venture and angel investing and common sense steps for fundraising for Medical Device Startups. No one is an expert now.
What’s happening in Banking World?
The entire landscape is very competitive and banks today are evolving. Banks are relying more and more on technology to reach customers and deliver services in short span of time. It is becoming important for them to be consistent and deliver quality customer services using technology to reach, expand and deliver faster and better services.
Adding additional services and transactions via technology, integrating with legacy systems and delivering using new delivery methods are becoming a norm. The banking industry is embracing newer technology to grow their market share. With technology, banks today are global players and no more local.
Challenges
Challenges in the multiple industries are similar but in Banking, there are specific challenges, which makes it unique, which are
• Frequently changing market and regulatory requirements
• High data confidentiality requirements
• Complex system landscapes including legacy systems
• Newer technologies such as mobile and web services
• Enterprise banking integration – Core banking, Corporate Banking and Retail Banking
• Application performance – Internal and External
Approaches to meet the challenges
It is very important that banks and financial establishments conduct regression tests over the entire application lifecycle for every release and also maintain test suites for each release using effective version control system linked to requirements, test cases, test scenarios and realistic test data. Based on this, an effective testing approach can be taken individually or by combination of the following to achieve the desired results:
• Risk-based testing
• Automation - Legacy, Web, Mobile
• Test data management
• Compliance / Statutory testing
• Performance and Capacity engineering
• Off-shoring
Tata Elxsi is an ISO-13485 certified product design house. Our quality management system, tailored to the medical device industry meets the requirements of ISO 13485, ISO 14971, ISO 9001, IEC 62304, IEC-60601, 21 CFR Part 820, CE & EU directives and other equivalent requirements.
The Business Case for On-Demand Test ServicesCognizant
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On-demand services offer a superior alternative to traditional QA service delivery models by providing a pay-per-use approach and enabling greater operational agility.
Corrective actions current expectation of iso 13458 & fda auditorsOnlineCompliance Panel
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Webinar will provide an understanding of current expectations of ISO 13485 notified body auditors regarding containment or correction of nonconformity.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
Self-Audits – Crucial for Your Medical PracticeJessica Parker
Â
Auditing is important to evaluate the physician processes to make sure their compliance plan is operating correctly and to identify any inappropriate documentation, coding, and/or billing practices. One of the most important reasons for auditing is to identify any potential areas of concern that could put the physician or practice at risk for audits.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Automated System Validation in FloridaAndre Butler
Â
The ADB Consulting services are providing a different type of services like as: - Automation System Validation & more. An Automated system validation must be carried out for manufacturing processes to be flawless and a success. Validation of an automatic system helps ensure.
A presentation delivered June 4, 2009 describing the impact of the economic crisis on venture and angel investing and common sense steps for fundraising for Medical Device Startups. No one is an expert now.
What’s happening in Banking World?
The entire landscape is very competitive and banks today are evolving. Banks are relying more and more on technology to reach customers and deliver services in short span of time. It is becoming important for them to be consistent and deliver quality customer services using technology to reach, expand and deliver faster and better services.
Adding additional services and transactions via technology, integrating with legacy systems and delivering using new delivery methods are becoming a norm. The banking industry is embracing newer technology to grow their market share. With technology, banks today are global players and no more local.
Challenges
Challenges in the multiple industries are similar but in Banking, there are specific challenges, which makes it unique, which are
• Frequently changing market and regulatory requirements
• High data confidentiality requirements
• Complex system landscapes including legacy systems
• Newer technologies such as mobile and web services
• Enterprise banking integration – Core banking, Corporate Banking and Retail Banking
• Application performance – Internal and External
Approaches to meet the challenges
It is very important that banks and financial establishments conduct regression tests over the entire application lifecycle for every release and also maintain test suites for each release using effective version control system linked to requirements, test cases, test scenarios and realistic test data. Based on this, an effective testing approach can be taken individually or by combination of the following to achieve the desired results:
• Risk-based testing
• Automation - Legacy, Web, Mobile
• Test data management
• Compliance / Statutory testing
• Performance and Capacity engineering
• Off-shoring
Tata Elxsi is an ISO-13485 certified product design house. Our quality management system, tailored to the medical device industry meets the requirements of ISO 13485, ISO 14971, ISO 9001, IEC 62304, IEC-60601, 21 CFR Part 820, CE & EU directives and other equivalent requirements.
The Business Case for On-Demand Test ServicesCognizant
Â
On-demand services offer a superior alternative to traditional QA service delivery models by providing a pay-per-use approach and enabling greater operational agility.
Corrective actions current expectation of iso 13458 & fda auditorsOnlineCompliance Panel
Â
Webinar will provide an understanding of current expectations of ISO 13485 notified body auditors regarding containment or correction of nonconformity.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
Maetrics: The ROI of Good Quality & ComplianceGeneris
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On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One.
Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit.
Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.
Best Practices for Rating and Policy Administration System ReplacementEdgewater
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Edgewater Technology, AQS and ISO joined forces to share best practices for replacing policy administration and rating systems for P&C insurance companies.
How much does it cost to launch and commercialize a companion diagnostic test?Diaceutics Group
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We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with.
We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance.
Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
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An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
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An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Access 2-healthcare , Company Introduction Deck - English - Aug 2017Access-2-Healthcare
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Access-2-Healthacare helps small / medium sized medical technology companies gain market entry to various countries, business due diligence, quality, regulatory approvals, trade compliance, software testing, business partnership, product commercialisation
Challenges of Software Testing in the Life SciencesAdam Sandman
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Inflectra partner SmarteSoft presented the challenges in testing in the life sciences, covering pharmaceuticals, providers (hospitals, etc.) and payers (insurance companies, health plans, etc.).
Similar to 9 regulatory compliance and validation for li (20)
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Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
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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.
Memorandum Of Association Constitution of Company.pptseri bangash
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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
[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
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
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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.
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Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Improving profitability for small businessBen Wann
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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.
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2. Life Sciences Industry Challenges
What Is Validation?
How Do You Sell It?
How Much Does It Cost?
What Is The Validation Toolkit?
Validation Automation – What You Need To Know
What Every Partner Should Know
3.
4. In 2011 the Pharma industry
will face negative growth
$ 62BN of sales will be lost to
Generics in the US by 2011
Pharmaceutical
Only 1 in 20,000 compounds
make it to market
Costs of taking a drug to
Market in US exceeds $1.4B
As much as 80% of revenue comes
from new products (< 2 yr old)
New regulations appear regularly
from both states and feds
Medical
Devices
Most hospitals have WiFi, but they
struggle with Device Mgmt
Biotechnology
Biosimilar legislation in US puts
billions of revenue at risk
5. • Disparate Systems
• Legacy Systems
• Huge Amounts of
Data/Records
• High Cost of Downtime
• Lack of Automation
Between Machines /
Systems
• Internal “Production Focus”
Metrics
• Many Manual Touch Points
• We Validate All GMP
Functionality In AX
11. GAMP 5® is an international
standard designed to harmonize
validation requirement across
the globe. It was written by a life
sciences industry consortium.
PARALLELS SURESTEP® METHODOLOGY
17. “…You have failed to validate
computer software for its intended
use according to an established
protocol, when computers or
automated data processing systems
are used as part of the production or
the quality system, as required by 21
CFR 820.70(i)…”
18. You have failed to document
maintenance activities, including
the date and individuals
performing those activities, as
required by 21 CFR 820.70(g)(1).
19. “…Failure to validate software used as part of
production and quality system for its
intended use according to an established
protocol, and failure to document the results
of the software validation, as required by 21
C.F.R. § 820.70(i)… Specifically, your firm has
not maintained documentation of the
validation of the computer software…”
20.
21.
22.
23. Think Validation FIRST!
Ask About Outsourcing Versus In-House Validation
Ask About Deployment Environment (Hosted/OnPremise)
Complete Validation Questionnaire With Prospect
Do NOT Quote Fixed Price (T&M Only)
Bring Validation Team In As Early As Possible
25. You do not have a clear understanding
of client requirements
Client is uncomfortable with your
knowledge of validation
You fail to give them a comfort level
with the services they will receive
You are caught in a price bidding war
You cannot answer their questions
during the sales process
30. Minimize Cost
Of Validation &
Verification
Rapid
Deployment
Of Dynamics
AX/NAV
Minimize
Risk
Across Project
Ensure
Compliance
With cGMP
Regulations
& 21 CFR Part
11
Maintaining
A Validated State
Over Time
31. IT Director/VP Who Understands Validation
SMB Pharma/Med Device/Biotech/CRO
Customer With Approved Budget
Knowledgable About Regulations
Significant ERP/Compliance Pain
32. Ask to speak to
QA regarding
their validation
process
Mention the
Validation
Toolkit as a
validation
starting point
AT THE
BEGINNING OF
THE SALES
CYCLE!
Ask Prospect
does the system
require
validation
upfront
33.
34. High Range
Medium Range
Low Range
• $100 - $200k
• OTB Installation
• $200 - $400k
• Some
Customizations
• $400 – 600k+
• Significant
Customizations
• Integrated 3rd Party
Applications
36. Don’t Understand Validation Requirements
Dont Understand The Industry Sector Challenges
Cant Speak the language of life sciences companies
Don’t Involve The Validation Team Early Enough
Don’t Adopt Validation Processes Into The Overall Implementation
Project
Validation is an AFTER THOUGHT
37. Listen!
Get The Right People Learn The Language
of Validation
In The Room
Establish Credibility
Early
Emphasize Value
Sharpen the Saw:
Commit To Life Long
Be Flexible: One Size
Learning &
Does Not Fit All
Improvement
47. • Allows Real Time OQ Test Script Execution In The Actual Software Environment
• Reports Failures During Execution
• Excellent For Re-validation Exercises
• Saves 60% of Testing Time
PROCEDURE CAPTURE IS OPTIONAL AND IS AVAILABLE FROM
ONSHORE TECHNOLOGY GROUP
51. No Understanding Of The
Validation Process
No Understanding Of
Regulatory
Requirements/Impact
Over-Customization
No Process Control
During AX Configuration/
Development
Failure To Establish
Change Control
Lack of Training
SmartArt custom animation effects: upward arrow process(Basic)To reproduce the SmartArt effects on this slide, do the following:On the Home tab, in the Slides group, click Layout, and then clickBlank. On the Insert tab, in the Illustrations group, click SmartArt. In the Choose a SmartArt Graphic dialog box, in the left pane, click Process. In the Process pane, click Upward Arrow (sixth row, third option from the left), and then click OK to insert the graphic into the slide.Select the graphic, and then click one of the arrows on the left border. In the Type your text here dialog box, enter text. (Note: To create a bulleted list below each heading, select the heading text box in the Type your text here dialog box, and then under SmartArtTools, on the Design tab, in the CreateGraphic group, click AddBullet. Enter text into the new bullet text box.)On the slide, select the graphic. Under SmartArtTools, on the Design tab, in the SmartArtStyles group, do the following:Click ChangeColors, and then under Colorful click Colorful Range - Accent Colors 3 to 4 (third option from the left).Click More, and then under Best Match for Document click Intense Effect (fifth option from the left).On the Home tab, in the Font group, select Calibri from the Font list, and then select 24 from the Font Size list.Select the text in the first text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickOliveGreen, Accent 3, Darker 25% (fifth row, seventh option from the left).Select the text in the second text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickAqua, Accent 5, Darker 25% (fifth row, ninth option from the left).Select the text in the third text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickPurple, Accent 4, Darker 25% (fifth row, eighth option from the left).To reproduce the animation effects on this slide, do the following:On the Animations tab, in the Animations group, click CustomAnimation.On the slide, select the graphic. In the CustomAnimation task pane, do the following:Click Add Effect, point to Entrance, and then click MoreEffects. In the Add Entrance Effect dialog box, under Basic, click Wipe. Under Modify: Wipe, in the Direction list, select From Left.Under Modify: Wipe, in the Speed list, select Fast.Also in the Custom Animation task pane, select the wipe effect. Click the arrow to the right of the wipe effect, and then click Effect Options. In the Wipe dialog box, on the SmartArt Animation tab, in the Group graphic list, select One by one.Also in the Custom Animation task pane, click the double arrow under the wipe effect to expand the contents of the list of effects.Also in the Custom Animation task pane, select the second wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects. In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select With Previous. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation taskpane, select the third wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select With Previous. Under Modify: Descend,in the Speed list, select Very Fast.Click the arrow to the right of the third wipe effect, and then click Timing. In the Descend dialog box, on the Timing tab, in the Delay box, enter 0.5.Also in the Custom Animation task pane, select the fourth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select On Click. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation taskpane, select the fifth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select After Previous. Under Modify: Descend,in the Speed list, select Very Fast.Also in the Custom Animation task pane, select the sixth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select On Click. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation task pane, select the seventh wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select After Previous. Under Modify: Descend,in the Speed list, select Very Fast.To reproduce the background effects on this slide, do the following:Right-click the slide background area, and then click Format Background. In the Format Background dialog box, click Fill in the left pane, select Gradient fill in the Fill pane, and then do the following:In the Type list, select Linear.In the Direction list, click Linear Right (first row, fourth option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 39%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following: In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click Olive Green, Accent 3, Lighter 60%(third row, seventh option from the left).To increase the size of the SmartArt graphic so that it spans the entire slide, do the following:On the slide, select the graphic. Point to the top right corner of the graphic border, until a two-headed arrow appears. Drag the top right corner of the graphic border into the top right corner of the slide. Point to the bottom left corner of the graphic border, until a two-headed arrow appears. Drag the bottom left corner of the graphic border into the bottom left corner of the slide.