This document provides an agenda and overview for a team building session to prepare employees for an FDA inspection. The session covers why successful inspections are important, who will be on the inspection team and what they will examine, what the company is doing to prepare, and what employees can do before and during an inspection to help it go smoothly. It emphasizes being prepared, knowing procedures, answering questions directly and honestly, and working as a team to ensure regulatory compliance and consumer safety.
This French quiz will test your students' knowledge of fall-themed words. Turn this into a game by separating kids into groups and see who can get more answers right!
How to test infrastructure code: automated testing for Terraform, Kubernetes,...Yevgeniy Brikman
This talk is a step-by-step, live-coding class on how to write automated tests for infrastructure code, including the code you write for use with tools such as Terraform, Kubernetes, Docker, and Packer. Topics covered include unit tests, integration tests, end-to-end tests, test parallelism, retries, error handling, static analysis, and more.
本簡報是 Will 保哥在 2016/6/24 於 CTJS 中台灣 JavaScript Conference 的演講簡報
[ 相關連結 ]
本次演講的 Live Demo 原始碼
https://github.com/doggy8088/ctjs2016-ng2demo
The Will Will Web記載著 Will 在網路世界的學習心得與技術分享
http://blog.miniasp.com/
Will 保哥的技術交流中心 (臉書粉絲專頁)
http://www.facebook.com/will.fans
Will 保哥的噗浪
http://www.plurk.com/willh/invite
Will 保哥的推特
https://twitter.com/Will_Huang
This French quiz will test your students' knowledge of fall-themed words. Turn this into a game by separating kids into groups and see who can get more answers right!
How to test infrastructure code: automated testing for Terraform, Kubernetes,...Yevgeniy Brikman
This talk is a step-by-step, live-coding class on how to write automated tests for infrastructure code, including the code you write for use with tools such as Terraform, Kubernetes, Docker, and Packer. Topics covered include unit tests, integration tests, end-to-end tests, test parallelism, retries, error handling, static analysis, and more.
本簡報是 Will 保哥在 2016/6/24 於 CTJS 中台灣 JavaScript Conference 的演講簡報
[ 相關連結 ]
本次演講的 Live Demo 原始碼
https://github.com/doggy8088/ctjs2016-ng2demo
The Will Will Web記載著 Will 在網路世界的學習心得與技術分享
http://blog.miniasp.com/
Will 保哥的技術交流中心 (臉書粉絲專頁)
http://www.facebook.com/will.fans
Will 保哥的噗浪
http://www.plurk.com/willh/invite
Will 保哥的推特
https://twitter.com/Will_Huang
Superfly is a conceptual iPhone app that allows users to find nearby transportation options. It uses the phone's location services to locate the nearest buses, subways, taxis, and displays them for the user. The user can set preferences like regular destinations to prioritize results. It also has a "Ping" feature that alerts nearby taxis if the user needs a ride, preferentially notifying those going in the user's destination direction. The core screens display lists of transportation options sorted by arrival time and allow getting more results.
Erik Johansson, The Green Man Studio on his work for Trouble BrewingBank of Ireland
The presentation given by Eric Johansson on his work on Trouble Brewing labelling and visual identity during Outstanding By Design on May 10th 2014 in Highbank Organic Orchard.
You can see more here: www.biabeag.com
The document provides guidance on building relationships through effective communication. It discusses presenting yourself positively, managing information by properly analyzing situations, presenting ideas clearly, acquiring and transferring knowledge, resolving conflicts constructively, and questioning decisions respectfully. Continuous self-improvement is key to strengthening relationships over time by refining one's communication skills. Maintaining professionalism in all interactions serves as an important foundation for building trust within relationships.
Honeypot to Semantic Web interest group at the BBCSimon Cross
Honeypot is a project by the BBC to develop personalized programming and content recommendations by storing collections of content around individual users, enabled by cross-platform APIs. It uses semantic tagging to help users make sense of large amounts of content and facilitate discovery and sharing. Developed by just two developers with UX support, Honeypot aims to prototype ways to surface personalized recommendations across multiple platforms like Facebook, BBC websites, and other social networks and gadgets.
The document discusses how social networks have expanded and become more complex, with people now able to interact within and across networks through online platforms. It notes that businesses and entrepreneurs can learn lessons from this change, as personal networks were previously more segregated and relied solely on face-to-face interactions, which led to high attrition rates. The presentation provides a case study on how the matrimonial industry has been impacted and gives examples of how social networks now grow organically across different parts of people's lives from school to work.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
The document provides guidance for employees on preparing for and participating in an FDA inspection of their facility. It discusses why inspections are important, who will be on the inspection team and what they will examine. It offers advice on what employees can do before, during and after an inspection to help ensure it is successful, such as keeping work areas clean and orderly, being prepared to answer questions directly and honestly, and not guessing if an answer is unknown. The overall goal is to demonstrate the company's commitment to regulatory compliance, quality assurance and continuous improvement.
Superfly is a conceptual iPhone app that allows users to find nearby transportation options. It uses the phone's location services to locate the nearest buses, subways, taxis, and displays them for the user. The user can set preferences like regular destinations to prioritize results. It also has a "Ping" feature that alerts nearby taxis if the user needs a ride, preferentially notifying those going in the user's destination direction. The core screens display lists of transportation options sorted by arrival time and allow getting more results.
Erik Johansson, The Green Man Studio on his work for Trouble BrewingBank of Ireland
The presentation given by Eric Johansson on his work on Trouble Brewing labelling and visual identity during Outstanding By Design on May 10th 2014 in Highbank Organic Orchard.
You can see more here: www.biabeag.com
The document provides guidance on building relationships through effective communication. It discusses presenting yourself positively, managing information by properly analyzing situations, presenting ideas clearly, acquiring and transferring knowledge, resolving conflicts constructively, and questioning decisions respectfully. Continuous self-improvement is key to strengthening relationships over time by refining one's communication skills. Maintaining professionalism in all interactions serves as an important foundation for building trust within relationships.
Honeypot to Semantic Web interest group at the BBCSimon Cross
Honeypot is a project by the BBC to develop personalized programming and content recommendations by storing collections of content around individual users, enabled by cross-platform APIs. It uses semantic tagging to help users make sense of large amounts of content and facilitate discovery and sharing. Developed by just two developers with UX support, Honeypot aims to prototype ways to surface personalized recommendations across multiple platforms like Facebook, BBC websites, and other social networks and gadgets.
The document discusses how social networks have expanded and become more complex, with people now able to interact within and across networks through online platforms. It notes that businesses and entrepreneurs can learn lessons from this change, as personal networks were previously more segregated and relied solely on face-to-face interactions, which led to high attrition rates. The presentation provides a case study on how the matrimonial industry has been impacted and gives examples of how social networks now grow organically across different parts of people's lives from school to work.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
The document provides guidance for employees on preparing for and participating in an FDA inspection of their facility. It discusses why inspections are important, who will be on the inspection team and what they will examine. It offers advice on what employees can do before, during and after an inspection to help ensure it is successful, such as keeping work areas clean and orderly, being prepared to answer questions directly and honestly, and not guessing if an answer is unknown. The overall goal is to demonstrate the company's commitment to regulatory compliance, quality assurance and continuous improvement.
The document provides strategies and advice for job success, retention, and advancement. It discusses the importance of soft skills like dependability, reliability, cooperation, and maturity. It also addresses making good impressions, getting along with coworkers and supervisors, dealing with conflicts, and maintaining a positive self-concept to improve job performance and opportunities for promotions. Quizzes are included to self-assess areas for professional development.
Recipe for a Successful Inspection examines the proven recipe for a successful inspection. This recipe has been proven successful over time through many inspections by most credentialing agency. Four simple ingredients can prepare any person in any location to meet the challenges of an inspection.
Henk Bolhuis, Product Specialist CRO at Reprise Digital, Netherlands’ leading digital marketing agency, talks about making experiment outcomes & learnings stick in the audiences’ minds, about understanding why communication is key to the success of a good experimentation program, and more.
This document outlines 10 rules and expectations for students in Chef Dan's class. Students must be on time, prepared for class with the proper uniform and materials, contact Chef Dan if they will miss class, take thorough notes during lectures and demonstrations, get along with others, and understand that they will be graded daily based on clear criteria. Chef Dan's role is to teach, mentor, and help students achieve their dreams in the culinary industry.
Joan Winchester - Usability Testing on a DimePlain Talk 2015
"Usability Testing on a Dime: What, Why, and How" was presented as part of the Center for Health Literacy Conference 2011: Plain Talk in Complex Times by Joan Winchester, Consultant, Center for Health Literacy.
Description: Learn the basics of using cost-efficient field testing to find out whether your website or document works. Learn why field testing is important and gain insight into how people really receive your messages. Learn how to write and deliver a successful field testing interview.
Bar review-methods-and-techniques-abuelCharlou Gala
This document discusses the importance of preparation for the Bar exams. It emphasizes that success comes through preparation, not chance, and outlines six key factors to consider in preparing: mental preparedness, emotional preparedness, physical well-being, place and method of review, review materials, and timetable. For each factor, it provides guidance on effective strategies such as self-assessment of knowledge, dedication, a healthy lifestyle, choosing a review location and buddy, and selecting the most useful study materials. Overall, the document stresses that the Bar exams require thorough and methodical preparation over several months in order to maximize one's chances of success.
22 Deadly Sins, that causes people to Walk Out, Ask for Their Money Rack, Send Letters of Complaint and in Other Ways Torpedo Your Speaking, and Training Efforts.
Reverse brainstorming is a technique that combines traditional brainstorming with reversing the problem statement to generate more creative solutions. The document describes applying reverse brainstorming to problems faced by an insurance claims team. Instead of brainstorming how to solve issues like missing documents, the team asked how they could cause those problems. This generated 13 potential issues, which were then treated as problems to solve. The technique helped the team think more expansively about improving their claims process.
The document discusses a "Third Way" perspective for achieving goals and moving past failures. It advocates setting clear goals and breaking them into manageable steps. It also recommends addressing self-doubt by gaining perspective on past failures using facts and discovering lessons learned ("PFD"). The Third Way approach involves regular coaching sessions to set goals, track progress, and use the PFD method to overcome obstacles from a neutral perspective.
Nursing interview preparation booklet from staff giantstaffgiant
Finding qualified ability in medicinal services is definitely challenging one. So different number of enrollment organizations are there to tackle this issue by recognizing best-fit applicants from assets over the web. They are interestingly arranged to address issues the healthcare industry is confronting. They comprehend the employing needs of the restorative business and give the honest to goodness suitable answer for the therapeutic business. The Nursing recruitment consultancy comprehends your prerequisites and furnishes you with the accomplished and capable Nurses, Pharmacists, Perfectionists, Research Staff, and Hospital workforce. The enrollment consultancy conveys to you the best ability in Health Care and Medicine industry with a bother-free searching and arrangement strategy.
At the 2014 ICT Business Summit in Singapore. I took the audience through a practical journey on the principles and uses of Lean Startup and Human Centred Design. Learn from the likes of Steve Blank, Will Evans, Eric Ries and Brant Cooper to accelerate your rate of failure, and double the speed of success
8 common Interview question and answers - Job Interview SkillsPrasanjitChandraBarm
This document provides an overview of common interview questions and how to best answer them. It discusses 8 common questions that interviewers ask, including "Tell me about yourself", "What are your strengths/weaknesses?", "Where do you see yourself in 5 years?", and "How do you handle pressure?". For each question, it explains what the interviewer is looking for and provides examples of strong answers to help interviewees prepare and feel confident in an interview situation. The overall purpose is to help job applicants understand common interview questions and give successful responses.
Techniques for getting the conversation right when you talk to your customers and users, for analyzing your data and modeling that data into personas. Anyone can do this!
Work ethics refer to moral principles and standards of proper workplace conduct. Common work ethics for employees to follow include honesty, punctuality, integrity, loyalty, teamwork, productivity, reliability, commitment to excellence, positive attitude, cooperation, and professionalism. Professionalism involves appropriate dress, language, and asking for help. Employees should dress professionally for their role, use language suitable to the workplace, and seek assistance if unsure how to handle a situation. Maintaining proper work ethics fosters trust and benefits both employees and their organization.
The document provides information on successful field training, including the learning process, prospecting, mindset, and purpose of kitchen table presentations. The learning process involves hearing, writing, reading, and saying techniques repeatedly to achieve retention, utilization, and reinforcement. Prospecting should always present the opportunity first. The field training mindset advocates training before becoming licensed to earn more money faster. Kitchen table presentations aim to show people how the presenter can help them become clients or recruits.
This document provides guidance on preparing for and succeeding in a phone interview. It discusses researching the company and position, preparing answers to common questions, preparing questions to ask, and ensuring your environment is optimal. The key steps are to research thoroughly, craft strong answers to typical questions, and prepare both questions for the interviewer and your environment so you can make a great impression despite not being in-person.
This document summarizes a webinar on emotional intelligence and workplace productivity delivered by Dr. Pratik P. Surana. It provides background on the speaker, including his qualifications and experience in training. It then discusses key topics from the webinar, including definitions of emotional intelligence, its five essential competencies, and how it relates to self-awareness, self-control, and organizational commitment. The document recommends books on emotional intelligence and provides details for participants to contact the speaker or take an emotional intelligence assessment.
This document provides tips for preparing for a job interview, including what documents to submit, how to submit them, example interview questions, and what not to do during an interview. It recommends submitting a cover letter, CV, copies of qualifications and licenses, and any other required documents. It provides tips for properly submitting and organizing documents. It then lists and categorizes example interview questions in areas like introductory questions, personal motivation, past experience, supervision, job performance, flexibility, stress, organization, problem solving, and managing supervisors. Finally, it lists things not to do in an interview like arriving late, dressing hastily, smoking, drinking, chewing gum, bringing others, and failing to research the company.
Similar to Team Building For An FDA Inspection - The Employee Review (20)
This document provides guidance and examples for train-the-trainer programs for FDA regulated companies. It includes an introduction explaining the purpose and how to use the guidebook. The bulk of the document consists of examples and templates for developing training programs, including training plans, procedures, documentation, and assessments. It also includes sections on adult learning theory, developing training materials, conducting on-the-job training, assessing techniques, and using job aids to complement training. The document aims to improve training effectiveness by providing systematic training techniques and skills for subject matter experts conducting one-on-one or small group training.
There are three universal reasons why leaders fail to meet expectations: 1) they don't manage resources and events to benefit others, 2) they don't care for, guide and direct others, and 3) they don't exercise foresight to help others. To be a successful leader, one must be a steward who manages resources for others' benefit, a shepherd who cares for and guides others, and a seer who uses foresight to help others. Effective leaders exhibit these three fundamental leadership behaviors.
The document introduces decision analysis and uses selecting a U.S. presidential candidate as an example. It outlines the process of decision analysis, including identifying needs and wants. For presidential candidates, needs include meeting the constitutional requirements of age, citizenship status and term limits. Wants may include a candidate's values, experience and education level. The document provides details on the qualifications for U.S. president from the constitution and analyzes some potential 2016 Republican candidates using decision analysis.
The document outlines 10 things the author wishes they knew earlier in their leadership career. These include: 1) The OODA loop model of observe, orient, decide, act; 2) The process model of input-process-output; 3) Situational appraisal of problems, potential problems, decisions, opportunities; 4) Prioritizing spirituality, health, family, finances, development and growth; 5) The leadership model of communicate, motivate, educate, administrate; 6) The capability model of awareness, belief, comprehension, performance, excellence; 7) Understanding different personality types; 8) The culture model of how tools shape language, institutions, and art; 9) The team model of forming, storm
This one-page document provides an overview of a project management basics training workbook. It notes that the workbook is designed to teach project management fundamentals to new project team members. It will cover both technical and behavioral aspects of project management through lessons in each of the five stages of a project life cycle from initiation to close. The workbook aims to help participants more effectively contribute to and lead project work by understanding roles, responsibilities, and best practices.
The document outlines a project management basics workshop that provides an introduction to project management concepts and techniques. The workshop covers key principles of project management, technical aspects like process groups and knowledge areas, and behavioral skills like effective communication and problem solving. Participants will learn project management fundamentals through exercises and apply them to mapping, initiating, planning, and leading mock projects.
The document discusses regulatory compliance and the responsibilities for ensuring compliance at all levels of an organization. It states that leadership is responsible and accountable for compliance performance. It also notes that compliance consultants can help organizations by simplifying, eliminating waste from, and accelerating compliance efforts. The document emphasizes that compliance is a performance requirement for the entire organization from executive leadership down to individual employee job functions and tasks.
Project management involves using limited resources over a fixed period of time to achieve specific goals. It requires both technical skills and managing behavioral aspects. The document outlines the basic processes and knowledge areas of project management according to PMBOK, including initiating, planning, executing, controlling, and closing projects. It emphasizes understanding stakeholders by answering who they are, what they need, how their performance will be measured, and managing expectations, perceptions, and issues.
Saint Andrew's Church in Soham, Cambridgeshire has a history dating back to the 12th century. It was built on the site of a Saxon cathedral from 900 AD. The church contains remnants of medieval architecture and furnishings. It underwent a restoration in 1880 that removed galleries and repaired the roof and flooring. The church records baptisms from 1558, marriages from 1599, and burials from 1558.
The document discusses trends in GMP (good manufacturing practices) compliance in the pharmaceutical industry from 2012. The top six trends are: 1) Increasing number of inspections, 2) Increasing number of warning letters, 3) Increasing enforcement penalties, 4) Increasing harmonization between regulatory agencies, 5) Increasing use of science and technology, and 6) Increasing use of subject matter experts. The document emphasizes that knowledge of these compliance trends can help companies improve processes, avoid citations, and strengthen standard operating procedures.
An overview of the Quality Systems Investigation Technique used by the Food and Drug Administration (FDA) for on-site inspections. Presented here as a tool for business and industry to use as a guide for internal and external audits and inspections.
This document provides an overview of a quality systems approach. It discusses key elements like design controls, production and process controls, corrective and preventive actions, management reviews, and continuous improvement. The quality system aims to design quality in from the beginning, execute according to design, and monitor and control through quality assurance. It also discusses applying this approach to pharmaceutical development and manufacturing through concepts like an integrated validation master plan and quality evaluations.
A guide for use by Business and Industry to design, or, upgrade training and performance management documents and processes. This is a companion piece to the Corporate University Catalog on SlideShare.
Time Management: for establishing and controlling your prioritiesMitchell Manning Sr.
Time Management: skills, tools, and techniques for taking control of information overload, telephone calls, interruptions, clutter, technology, and work.
A collection of slides showing skills, tools, and techniques for achieving balance, synergy, and leverage in your personal and professional life.
This MSPPT presentation is a companion piece for the MSWord presentation by the same name on SlideShare.
The document is a fable about achieving work-life balance and empowerment in organizations. It tells the story of the CEO of MegaCorp who is unhappy with the lack of empowerment and ownership among employees. At a board meeting, a supervisor named Trent suggests they focus on balance, synergy, and leverage to empower employees. The CEO asks Trent to develop an empowerment plan. Trent discusses his ideas with the VP of HR, focusing on self-direction, self-development, and self-discipline. The fable promotes empowering employees to make their own decisions to increase productivity and satisfaction.
Job aids for initiating, planning, executing, controlling, and closing projects for project team members and project managers.
The project management presentation for the 23rd Annual Southeast ASQ FDC/FDA Conference held February 12, 2010.
Starting a business is like embarking on an unpredictable adventure. It’s a journey filled with highs and lows, victories and defeats. But what if I told you that those setbacks and failures could be the very stepping stones that lead you to fortune? Let’s explore how resilience, adaptability, and strategic thinking can transform adversity into opportunity.
Dive into this presentation and learn about the ways in which you can buy an engagement ring. This guide will help you choose the perfect engagement rings for women.
HR search is critical to a company's success because it ensures the correct people are in place. HR search integrates workforce capabilities with company goals by painstakingly identifying, screening, and employing qualified candidates, supporting innovation, productivity, and growth. Efficient talent acquisition improves teamwork while encouraging collaboration. Also, it reduces turnover, saves money, and ensures consistency. Furthermore, HR search discovers and develops leadership potential, resulting in a strong pipeline of future leaders. Finally, this strategic approach to recruitment enables businesses to respond to market changes, beat competitors, and achieve long-term success.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Garments ERP Software in Bangladesh _ Pridesys IT Ltd.pdfPridesys IT Ltd.
Pridesys Garments ERP is one of the leading ERP solution provider, especially for Garments industries which is integrated with
different modules that cover all the aspects of your Garments Business. This solution supports multi-currency and multi-location
based operations. It aims at keeping track of all the activities including receiving an order from buyer, costing of order, resource
planning, procurement of raw materials, production management, inventory management, import-export process, order
reconciliation process etc. It’s also integrated with other modules of Pridesys ERP including finance, accounts, HR, supply-chain etc.
With this automated solution you can easily track your business activities and entire operations of your garments manufacturing
proces
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
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The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
Each framework is presented with visually engaging diagrams and templates, ensuring the content is both informative and appealing. While this compilation is thorough, please note that the slides are intended as supplementary resources and may not be sufficient for standalone instructional purposes.
This compilation is ideal for anyone looking to enhance their understanding of innovation management and drive meaningful change within their organization. Whether you aim to improve product development processes, enhance customer experiences, or drive digital transformation, these frameworks offer valuable insights and tools to help you achieve your goals.
INCLUDED FRAMEWORKS/MODELS:
1. Stanford’s Design Thinking
2. IDEO’s Human-Centered Design
3. Strategyzer’s Business Model Innovation
4. Lean Startup Methodology
5. Agile Innovation Framework
6. Doblin’s Ten Types of Innovation
7. McKinsey’s Three Horizons of Growth
8. Customer Journey Map
9. Christensen’s Disruptive Innovation Theory
10. Blue Ocean Strategy
11. Strategyn’s Jobs-To-Be-Done (JTBD) Framework with Job Map
12. Design Sprint Framework
13. The Double Diamond
14. Lean Six Sigma DMAIC
15. TRIZ Problem-Solving Framework
16. Edward de Bono’s Six Thinking Hats
17. Stage-Gate Model
18. Toyota’s Six Steps of Kaizen
19. Microsoft’s Digital Transformation Framework
20. Design for Six Sigma (DFSS)
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Team Building For An FDA Inspection - The Employee Review
1. Team Building
for an FDA Inspection:
Adapted by Mitchell W. Manning Sr. from
presentations by former FDA Investigators
The Employee Review
2. 2
Agenda
Introduction/Overview
What can I do prior to the inspection?
What can I do during the inspection?
How do I answer an investigator’s questions?
Role Play and Experience Scenarios
Inspection Jeopardy (team competition)
Wrap up and questions
3. 3
Introduction/Overview
Why do we need a successful
inspection?
Who’s on the inspection team?
What will they look at?
What is our company doing?
4. 4
Why do we need a successful
inspection?
Regulatory action
Approvals / Contracts
Ensures consumer safety
Stockholder / Market issues
Your professional reputation
Freedom from legal problems
Stakeholder – You the employee
Verify our continuous improvement process
5. 5
Who’s on the inspection
team?
Chemists
Engineers
Investigators
Microbiologists
Computer Specialist
Headquarters Reviewer
6. 6
What will they look at?
Computers
Procedures
Complaints
Rejected batches
Laboratory controls
Overall facility
Buildings, equipment,materials, cleaning
procedures, HVAC, etc.
7. 7
What will they look at? (Cont’d)
Labels
Components
In-process materials
Validation processes
Finished/released materials
Logbooks, records and documents
Areas not looked at before-Be Ready
8. 8
What is Our Company doing?
Counting heavily on your performance.
Providing extensive cGMP training to all
employees.
Using extensive resources internally
and from outside sources.
Taking broad steps to elevate the
importance of the expected FDA
inspection.
9. 9
What is Our Company doing?
(cont’d)
Identifying inspection coordinators.
Developing an inspection response plan.
Establishing communication procedures.
Designating key personnel responsibilities.
Establishing written policies--photos;
recordings; etc.
Enhancing our continuous improvement
process.
10. 10
What can I do prior to the
inspection?
Support preparation efforts.
Ensure your work area is neat and orderly.
Ensure your area equipment and instruments
are clean and calibrated.
Ensure your logs and production documents
are filled out completely, accurately and
legibly at time of performance.
11. 11
What can I do prior to the
inspection? (Cont’d)
Be prepared.
Know your job.
Encourage your fellow workers.
Expect high quality in all your work-
accept nothing less.
Remember: First impressions are
lasting Impressions;
Employees, facilities and
documents make a lasting
impression with the FDA!
12. 12
What can I do during the
inspection?
Listen carefully to questions.
Don’t assume you know the question.
Answer only after the question is fully
stated.
Be confident of your answer. If you
don’t know, say so.
Avoid bragging about your area.
13. 13
What can I do during the
inspection? (cont’d)
Don’t be nervous.
Re-review all your procedures.
Provide only what is asked for.
Don’t leave documents out on your desk.
Keep your area clean. Be ready any day!
Be proud of your area but the best of things
are left unseen.
14. 14
How do I answer an
investigator’s questions?
Do’s
Don’ts
19. 1. Documentation should occur
when?
a b
c d
When I get some free
time
At the time I perform the
activity
When it does not
conflict with my break
time
Anytime during your
shift
20. 2. How do you know how to do
your work?
a b
c d
I was trained on the
process and I have
performed this job many times
I watched Bill do it a couple
of times and they let me give
it a try
Give me one second
and I will tell you if
I can do it
I was trained on the
process and I have
performed this job many
times. Do you want to see
21. 3. Where is the procedure?
a b
c d
Right here in my desk
I have access and can read
procedures from the area
computer
I was taught by one of the
old-timers who taught me
everything I know
See this tattoo on my
right arm. Did that 2
years ago
22. 4. How do you know that you are
using the latest procedure?
a b
c d
Well, it is the only one
available in my area
I think so. I am not
sure this is the right
procedure
Yes, I just verified it on
our computer
I don’t know. My supv.
tells me what to do, when
to Breath, eat, and sleep
23. 5. When were you trained on
your SOP?
a b
c d
I didn’t need any training.
I knew how when I came here
I don’t recall the exact
date, I was trained
when I first came on
the job
About 10 years ago
Sorry, I am too busy
reading this procedure
for the first time
24. 6. When your SOP procedure is
revised, are you trained on the
revisions?
a b
c d
Yes, we had a formal
training session on the
revisions two weeks ago
Well, sort of. Someone pointed out
the changes to the procedure,
and I figured it out from there
Revised! I have not been
trained on the original
procedure yet
Heck No. We are good
here. We just do it
and make it happen
25. 7. Is this your password written
down on this paper & stuck to the
monitor?
a b
c d
Yes! Listen, I have so many
Passwords. I just leave it
here so I can remember
No! My password is
always secure
No, we were told to take
them off the computer
till you left
No! I use my social
security number. …
218-56-2311
26. 8. This procedure has been
revised, were you trained on the
revisions?
a b
c d
Yes, we had a formal
training session on the
revisions two weeks ago
Well, sort of. Someone pointed out
the changes to the procedure,
and I figured it out from there
Not yet. I’m scheduled for the
formal training next week
Heck No. We are good
here. We just do it
and make it happen
27. 9. Do you shut down your
computer when you go to lunch?
a b
c d
Yes! I secure my
computer
Shoot No! Why, half the
people here can’t read
any way
No, I just turn off my monitor
and people think it is off
No, the dot matrix
screen is closed by the
vertical key lock mode
28. 10. What do you do if the
product could be defective?
a b
c d
Keep my mouth shut
and keep on trucking
Pull out my old
procedures and fix it like
we use to
Contact my supervisor and
follow relevant procedures
Taste the product and
see if the defective
product passes our
taste test
29. 11. Why are you using that
procedure?
a b
c d
Oh, just doing my own
thing
I am following the
procedures for this
process. Let me show
you
I am following the procedures
for this process
If I do it this way, it
makes the pills taste
better
30. 12. What will be checked during
the inspection?
a b
c d
The type, make and
model of employee cars
Employee foot smell in
reference to water
quality in our facility
Overall facility, complaints,
procedures, reject batches,
laboratory controls &
computers
The cost of eggs in
china and the number
of eggs consumed in
our cafeteria
31. 13. What will the inspectors be
looking for?
a b
c d
A free meal in our
cafeteria
In-Process & finished
products, labels,
validation process,
logbooks and people
A date since most of the
inspectors travel a lot and have
little to no social life
A good time
32. 14. How does this inspection
relate to our continuous
improvement?
a b
c d
Continuous
Improvement Process !
Do we have a new
product?
Continuous WHO
Nothing! It means we
can go back to our old
ways when they leave
This inspection assists us
in providing the best
product to our customer
for now and in the future
33. 15. What can I do prior to the
inspection?
a b
c d
Plan a vacation and not
be here when they arrive
Do the same thing I have
always done
Housekeep, document,
follow procedures,
know my job, help
fellow employees
Read a good novel
34. 16. What can I do during the
inspection?
a b
c d
Plan a vacation and not
be here when they arrive
Be confident, listen, avoid
bragging, answer question only,
and don’t assume
Run around shouting ,
screaming and acting
crazy so they will not
ask me any questions
Go to my usual hiding
place and stay there
35. 17. Is “I do not know” an
acceptable answer?
a b
c d
Yes only when your
significant other asks
you to spend money
Yes. If you do not know then
tell the inspector that you do
not know
Only if it does not
reference the standard
size of chocolate chip
cookies
No. You should know
everything
36. 18. How should you answer an
inspector’s questions?
a b
c d
With “Sir Yes Sir”
While standing on one foot Directly and
honestly-- do not
ramble
In French
37. 19. Who can make this
inspection a success?
a b
c d
I – YOU – WE – US
(TOGETHER)
Santa Claus Bob Smithinson
The employees that stay
home the day of the
inspection
40. 40
CGMP Critical Elements
Be clean.
Know your job.
Control for quality.
Write your procedures.
Follow your procedures.
41. 41
CGMP Critical Elements
Maintain your area equipment.
Audit your work for compliance.
Document your work processes when
performed.
Good people like you with high
personal character.
42. 42
Today is the first day of
your Opportunity to “make
a Difference” in the
Success of Our Company