Bio Medical Certification

Transcription

1 Bio Medical Certification Course No. 325 / DET Course ID: This course consists of 4 courses which prepare students in Lean Six Sigma (Green Belt), BIO Medical Auditing, ISO 9001/ISO 13485, and in Regulatory Courses. Attendees learn to integrate Lean Six Sigma and Quality Operations Management methodologies. none Type of Training Classroom, Exercises, Workshops & Coaching. Course Description This consists of a series of courses for 7 weeks, averaging 26 hours per week. These courses prepare students to have the knowledge and skills in Lean Six Sigma Green Belt, Regulatory Affairs, BIO Medical Auditing, Quality Engineering and ISO 9001/ISO Days Timing Courses 9 days (72 hours) 9am to 5pm Lean Six Sigma Green Belt Certification 4 days (32 hours) 9am to 5pm Regulatory Affairs (Medical Device Regulations, Risk Management, Process Validation) 48 hrs 9am to 5pm 5pm to 9pm or 9am to 5pm arranged ISO 9001/ISO Auditing (24 hours) CQA/Bio Medical Auditing (24 hours) 4 days (32 hours) 9am to 5pm Quality Engineering Statistics None Expected Outcome: Lean Six Sigma Green Belt Certification (A certificate is provided upon passing the exam on the last day of class) BIO Medical Auditor (A certificate is provided upon passing the exam on the last day of the class); Prepared for CQA and ISO CQE Prep (A certificate is provided upon passing the exam on the last day of class) Duration Classroom - besides coaching and mentoring, 7 weeks, averaging 26 hours per week Total Cost $7,500 Registration QPS Training Administrator, Pam Martel info@qpsinc.comjay Patel (cell: , jayp@qpsinc.com), Jack Reardon (cell: , Jackr@qpsinc.com). You may call 24/7 for any questions during the training.

2 Lean Six Sigma Green Belt Certification Course No. 113A This course is designed for personnel who desire Lean Six Sigma backgrounds and Green Belt Certification. This course is based on ASQ s Green Belt Certification Body of Knowledge and covers all Lean Six Sigma aspects. Green Belts support Black Belts and also conduct small projects for improvement. Attendees learn to integrate Lean Six Sigma methodologies, to implement breakthrough improvements, to manage small scale Six Sigma projects and to support Black Belts in the deployment of Six Sigma techniques to achieve bottom-line success. : None Certification Requirements: Participants are required to participate in exercises and workshops in class and to successfully complete a written examination at the end of the class. Lean: week 1 (4 days) Introduction on Lean How to Implement Lean Process Mapping & Value Stream Mapping Kaizen Standardized Work Team Management Six Sigma: week 2 (5 days) Introduction Terminology Symbols, Acronyms & Abbreviations Lean Six Sigma Goals Toll Gate Review Process Define Teams & Customers Failure Modes and Effects Analysis Data & Process Analysis Probability Basic Statistics & Capability Measurement System Analysis Analyze Phase Improvement Techniques Control Concepts

3 Medical Device Regulations / QSR Course No. 135 This course has been designed to help you understand the Quality System requirements including FDA perspective and how to implement. Participants will understand the QSR, FDA requirements and how ISO 9001 and QSR can be deployed. None 1. What are QS Regulations 2. The FDA Philosophy 3. Medical Device Overview 4. Relationship to ISO standards 5. The Quality System Regulations 6. Quality Records 7. Regulatory Requirements and FDA expectations 8. Impact of QS Regulations on other industries 9. The Quality System Inspection Technique 10. Design Controls Understanding Medical Devices Regulations Individuals interested in learning the Medical Device Regulations which includes engineers, quality professionals, auditors, managers etc. For More Information: Contact Training Administrator: info@qpsinc.com, Telephone: (508) (508)

4 Risk Management For Medical Devices/Pharm. Course No. 132 This course has been designed to help you understand the requirements for understanding, analyzing and managing risk per ISO Understand the requirements of the ISO standard, determine documentation requirements, and how to implement. Participants will understand the requirements of the risk management process including plan, analysis, evaluation and risk reduction. None ISO 14971:2003 requirements Define risk, responsibilities Risk planning and analysis Scoring, evaluation, mitigation, risk benefits Management risk report Communication Post evaluation FDA perspective Transition process Individuals interested in learning how to implement ISO For More Information: Contact Training Administrator: Telephone: (508) (508)

5 Process Validation Course No. 136 This course has been designed to help you understand the process validation concepts for medical devices and pharmaceutical products.. Participants will understand the validation process None FDA requirements Validation concepts Planning Conducting verification and validation Documenting the process and results Individuals interested in learning how to conduct process validation. For More Information: Contact Training Administrator: Telephone: (508) (508)

6 Implementation and Auditing to ISO 9001:2008 Course No. 101 This course has been designed for personnel auditing QMS. It is for two days and includes one day of Course # 101A. This is to understand changes from ISO 9001:2000 to ISO 9001:2008, improving your QMS. The second day will be spent strictly on auditing. It covers how to plan, conduct and report system, process and product audits. Participants will be able to learn and understand the changes for the ISO 9001:2008 Quality Management System. Participants will get an official copy of the ISO 9001:2008 standard, CD with changes in the procedures, processes, forms and templates. : None Certification Requirements: Class attendance, participation and passing the exam. A certificate will be mailed to all attendees who attended and passed the examination. ISO 9001 requirements, ISO 9001 auditing, & how to implement them Key Learning Objectives: Day One: 1. Understand the specific changes from Standard ISO 9001:2000 to 9001: How to document the changes in Manual and Procedures 3. How to simplify documentation and make it user friendly 4. How to develop a world class management system 5. How to get management involved and make the system as part of the corporate plan 6. How to incorporate six sigma and lean concepts into ISO 9001 system 7. How to develop Performance Metrics for suitability, adequacy and effectiveness of your QMS 8. How to develop a process approach in your documentation examples Day Two: 1. Understand the auditing process 2. Review internal and supplier auditing procedures 3. How to develop the checklist and turtle diagrams 4. How to conduct the process audit 5. How to conduct the system audit 6. How to conduct the product audit 7. How to improve your auditing process Day One: Module 1: Principles of Quality Management Module 2: Changes from ISO 9001: 2000 to ISO 9001:2008 Module 3: Documentation Module 4: Effective CAPA Module 5: Effective Management Reviews Day Two: Module 1: Auditing basics and process (includes the role of the audit participants, types of the audit and audit basics) Module 2: Audit planning (Audit schedule, plan and developing the documentation) Module 3: Conducting system, process and product audits) actual audit exercises and workshops) Module 4: Continual improvements of your auditing process ( how to create an improvement culture, and the procedure) Module 5: Internal auditing and Supplier auditing procedures Procedures, Forms, Checklists, turtle diagram and Audit Report (CD will be provided), Sample Exam and Final Exam

7 Auditing to ISO (Includes Process Auditing) Course No. 131 This course has been designed to help you understand the requirements for auditing to ISO Understand the requirements of the auditing process; planning, auditing and reporting and follow up. Learn how to conduct system and process audits. Participants will learn how to develop a checklist, plan and execute the audit. None Certification Requirements Attendance and successfully passing the 2 hour exam. Principles of quality management Auditing process ISO requirements and evidence requirements Developing audit checklist and documenation Conducting the audit Process auditing Developing the audit report Follow up and CAPA process Improving the system Anyone interested in learning how to audit and improve the QMS. For More Information: Contact Training Administrator: info@qpsinc.com, Telephone: (508) (508)

8 ASQ- Certified Quality Auditor (CQA) Course Course No. 202 This refresher course is designed to review the body of knowledge required for the ASQ CQA exam. The course covers all the required areas of the body of knowledge, as specified by ASQ. The course will cover also 500+ questions for practice. Participants will learn the requirements of quality auditing and become a knowledgeable and more efficient auditor. This applies to both internal and external auditing. Being a Certified Quality Auditor will enhance your career and benefit your company by providing improved auditing capabilities. Our history shows 90% of the students passed at the first attempt who took this course Vs national average of 40-60%. ASQ s requirements for certification Material included: Primer, 1000 questions/answers CD, book and customized training binder ASQ s code of ethics Audit preparation Audit performance Corrective action and follow up Audit program management General knowledge and skills Auditors and individuals interested in learning how to audit to the applicable standards and in understanding ASQ BOK for the exam. For More Information: Contact Training administrator: info@qpsinc.com Telephone: (508)

9 Intermediate Statistics Course No. 153 This course has been designed to help you understand intermediate or analyze phase statistics. This also prepares for ASQ Certified Quality Technician, Certified Quality Engineer or Certified Six Sigma Black Belt exams. Provide you with an understanding of statistics and its use in problem solving. This course will help you prepare for Six Sigma Black Belt, CQT and CQE certification. Basic statistics background (course no. 152 or equivalent) Probability Distributions Discrete & continuous Binomial, poisson, normal, chisquare t & F tests Others Central Limit Theorem Mean, median, mode Standard deviation Probability plots Minitab analysis Multi-vari Analysis Data collection Minitab analysis Graphical analysis Power & Sample Size Hypothesis testing Determine sample size Types of errors T tests ANOVA Confidence Intervals Populations Calculations C.I. for means C.I. for standard deviations C.I. for proportions Hypothesis Testing Statistical hypothesis Types of errors P-values T tests Variance testing Correlation Regression Correlation & causation Correlation coefficient Regression line Goodness of fit Scatter plots Minitab analysis Quality professionals, engineers, analysts, managers and improvement teams looking to enhance their background in statistics and problem solving.

10 Lead Instructors Jay P. Patel, ASQ Fellow Jay P. Patel, possesses over 25 years of professional work experience in management and quality assignments, including consulting and training to many Fortune 500 clients and trained thousands of people. Jay has taught on site to several public and private companies. He has instructed ASQ, PMI and APICS Certification Courses besides GB, BB, DFSS and MBB. He has presented speeches and seminars to various organizations such as the Project Management Institute, American Production and Inventory Control Society, Institute of Industrial Engineers, American Society for Quality, and Society of Manufacturing Engineers. He holds 10 ASQ Certifications including Six Sigma Certified Black Belt. He has a Bachelor and Master Degrees in Engineering and MBA. He is a RAB-Quality System Lead Auditor. Jay holds PMI certifications. He is a certified Project Management Professional (PMP ), a certified Risk Management Professional (RMP ) and a certified Scheduling Professional (PMI-SP ). Jay has served as Project Management Institute, Institute of Industrial Engineers and ASQ. He has held a number of positions at Chapters and Region levels in all 3 organizations. Jay is the Chairman of ASQ NEQC (North East Quality Council). Jay has been the National Malcolm Baldrige Quality Award Examiner and is an ASQ Fellow. He has co-authored the Quality Council of Indiana s Six Sigma Black Belt & Green Belt Primers, which are used for ASQ Certifications. Jack Reardon Jack Reardon has over 30 years experience in the quality and business improvement field specializing in Quality Improvement. Jack s professional experience includes working in the manufacturing and service industries and provided training for Green Belt, Black Belt and Master Black Belt. Jack has successfully managed the quality systems and quality improvements of our clients. Jack has taught courses in Lean Six sigma for Yellow Belts, Green Belts, Black Belts and Master Black Belt. Jack is a certified Lean Expert, Master Black Belt and Design for Six Sigma Black Belt. A member of American Society for Quality for the last 15 years, he has been an active officer of ASQ North East Quality Council. He is a graduate of Northeastern, with a Bachelor of Science in Business Management.