FDA - Regulatory Compliance Program

FDA/Regulatory/Compliance

We are pleased to offer the following comprehensive selection of courses this semester at Quality & Productivity Solutions, Inc. (QPS), delivered through instructor-led remote learning. These courses or newly customized ones can be tailored to meet your organization’s specific needs.

Please contact us to discuss your training requirements.

Our organization provides a comprehensive portfolio of Regulatory, FDA, Quality and Compliance training programs covering medical devices, pharmaceuticals, biotechnology, food safety, and global standards.

Programs Include

ISO 9001 – Quality Management Systems
ISO 13485 – Medical Device QMS
ISO 14971 – Risk Management for Medical Devices
FDA QSR – Quality System Regulation
GMP – Good Manufacturing Practices
CAPA – Corrective and Preventive Action
510(k) – Premarket Notification
EU MDR / CE Marking
QSIT – Quality System Inspection Technique
Validation & Sterilization
HACCP & ISO 22000 – Food Safety
SQF – Safe Quality Food
MDSAP – Medical Device Single Audit Program
And more specialized compliance programs

Programs are designed to help companies meet regulatory requirements, strengthen quality systems, and improve audit readiness across all operational areas.

In addition to our established catalog, we also develop and deliver customized courses tailored to the unique needs of our clients. Whether the goal is employee training, regulatory compliance, audit preparation, or process improvement, we design targeted, practical, and industry-specific programs that support organizational excellence and regulatory success.

The following list shows some of the training topics which can be customized to meet your needs. Please contact us at training@qpsinc.com for details.

Full Course Catalog

Regulatory, FDA, Quality & Compliance

Following is a course listing for the many courses we have developed and delivered to hundreds of clients, though we add new courses consistently based on the needs of our clients. All are instructor-led, and are available on-site and online for your convenience. Please contact us at training@qpsinc.com for details. Public training topics with course brochures are listed in the Calendar.

FDA/Regulatory/Compliance

Following is a course listing for the many courses we have developed and delivered to hundreds of clients, though we add new courses consistently based on the needs of our clients. All are instructor-led, and are available on-site and online for your convenience. Please contact us at info@qpsinc.com for details. Public training topics with course brochures are listed in the Calendar.

Course #	Course Title
131B	Auditing to ISO 13485/FDA QSR
132	Risk Management ISO 14971
134	Managing FDA Inspection
135	Medical Devices Regulations
136	Process Validation
137	Complaints & CAPA (Corrective and Preventive Actions)
325	Bio Medical Certification
357	ISO 22000 Food Safety Management System
357A	Understanding and Implementing the BRC Global Standard for Packaging
357B	Documenting the BRC Global Standard for Packaging
358	510(K): Medical Device Process
359	CAPA for Medical Devices & Drugs
360	European Union (EU) Directives, European Conformity (CE) Marking, and Guidance Documentation
361	Design Control: Understanding, Implementation, and Improvement
362	GMP/ISO System Documentation
362B	Certified GMP Professional (CGMP)
363	QSIT – Quality System Inspection Technique
364	Medical Device Sterilization Planning
365	ISO 22000 FMS Overview
366	HACCP (Hazard Analysis and Critical Control Point) Overview
367	Hazard Analysis Critical Control Point (HACCP)
367A	Implementing Safe Quality Food (SQF) Systems
368	Internal Auditor – ISO 22000
368A	Internal Auditor – Safe Quality Food (SQF) Systems
369	Lead Internal Auditor – ISO 22000
372	Corrective & Preventative Action – CAPA
373	Sampling – ANSI Z1.4 & Z1.9 & C=0
374	Biomedical Certification Advanced
375	FDA Related Food Safety Certificate Program
378	Medical Device Single Audit Program (MDSAP) Training
379	EU MDR

Course #

Course Name

Hours

Days

131C

ISO 9001/13485/CGMP Certified Auditor

Contact for Schedule

ISO 9001/13485/CGMP Certified Auditor

Course No. 131C

Duration:

28 Hours / Contact for Schedule Days

Who Should Attend?

Managers, developers, QA, associates, project managers, product managers, and any other professionals who deal with software development/QA/Projects directly or indirectly.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

132

Risk Management ISO 14971

May 18-19

Risk Management ISO 14971

Course No. 132

This course has been designed to help you understand the requirements for understanding, analyzing, and managing medical device risk using ISO 14971:2007. Participants will understand the standard, determine documentation requirements, and develop implementation strategies. The course also describes the issues raised by the European Union version, EN ISO 14971:2012.

Course Benefits

Participants will understand the requirements of the risk management process including plan, analysis, evaluation and risk reduction.

Prerequisites:

Knowledge of medical device regulation

Duration:

14 Hours / May 18-19 Days

Topics Covered:

- Scope
- Terms and definitions
- General requirements for risk management
  - Risk management process
  - Management responsibilities
  - Qualification of personnel
  - Risk management plan
  - Risk management file
- Risk analysis
- - Risk analysis process
  - Intended use and identification of characteristics related to the safety of the medical device
  - Identification of hazards
  - Estimation of the risk(s) for each hazardous situation
- Risk evaluation
- Risk control
- - Risk reduction
  - Risk control option analysis
  - Implementation of risk control measure(s)
  - Residual risk evaluation
  - Risk/benefit analysis
  - Risks arising from risk control measures
  - Completeness of risk control
- Evaluation of overall residual risk acceptability
- Risk management report
Production and post-production information

Who Should Attend?

Individuals interested in learning how to develop and deploy risk methodologies including implementing ISO 14971.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

134

Managing FDA Inspection

Contact for Schedule

Managing FDA Inspection

Course No. 134

Prerequisites:

None

Duration:

7 Hours / Contact for Schedule Days

Instructor:

The seminar leader will be RAB Certified Auditor, ASQ Certified Quality Auditor, and ASQ Certified Black Belt with experience in implementing ISO 9001, ISO/TS 16949, AS 9100, Lean Six Sigma methodologies.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

135

Medical Devices Regulations QSR

Mar 18-20

Medical Devices 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.

Course Benefits

Participants will understand the QSR, FDA requirements and how ISO 9001 and QSR can be deployed.

Prerequisites:

None

Duration:

14 Hours / Mar 18-20 Days

Topics Covered:

What are QS Regulations
The FDA Philosophy
Medical Device Overview
Relationship to ISO standards
The Quality System Regulations
Quality Records
Regulatory Requirements and FDA expectations
Impact of QS Regulations on other industries
The Quality System Inspection Technique
Design Controls Understanding Medical Devices Regulations

Who Should Attend?

Individuals interested in learning the Medical Device Regulations which includes engineers, quality professionals, auditors, managers etc.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

136

Process Validation

Mar 18-20 Jun 09–10

Process Validation

Course No. 136

This course has been designed to help you understand the process validation concepts for medical devices and pharmaceutical products. This also covers the following:
• Determining which process must require validation
• Evaluate if the process is capable
• Monitors and controls for the process
• Statistical methods
• Software qualifications

Course Benefits

Participants will understand the validation process and master skills necessary to validate processes.

Prerequisites:

None

Duration:

14 Hours / Mar 18-20 Jun 09–10 Days

Topics Covered:

- Module 1 – Validation Concepts, Terms, and Definitions
  - Understand the basic concepts of process validation, including the need to validate
  - Identify conditions when process validation is required
  - State the QSR definition of process validation
  - Compare and contrast process output verification with process validation
  - Describe additional process requirements for validated processes
  - Compare and contrast IQ, OQ, and PQ
- Module 2 – The Requirements Framework
  - Understand the requirements framework from FDA, ISO 13485, and OSHA
  - State the requirements for process validation from the FDA QSR
  - State the requirements for process validation from ISO 13485
  - Explain the relationship between process validation and a) medical device reporting, b) corrections & removals, and c) risk management
  - Identify the guidance documents published by FDA that relate to process validation
  - Explain the role of sampling in determining the need for process validation
  - Compare and contrast Lock Out – Tag Out with Machine Guarding
- Module 3 – Process Validation Approaches
  - Module 3.1 – Example
  - Understand the typical approaches to process validation, the approaches that generated them, and a unified approach to implementation
  - Compare and contrast the QSR and ISO 13485 requirements for process validation
  - Define subsequent verification and its role in process validation
  - Compare and contrast prospective, concurrent, and retrospective validation
  - Compare and contrast installation, operational, and performance validation
  - State the five interlocking parts of validation
  - Explain the four process steps for each part
- Module 4 – Installation Qualification
- - Understand the elements typically included in Installation Qualification (IQ)
  - Define Installation Qualification and describe its role
  - State the QSR requirements for maintenance and describe how IQ contributes to conformity
  - State the QSR requirements to post inherent limitations or allowable tolerances for equipment
  - Identify the source for maintenance information
  - State why you should identify all energy sources
- Module 5 – Statistical Methods & Exercises
- - Review three common statistical approaches required for process validation
  - Review the process capability indices Cp and Cpk
  - Review the fundamentals of the x-bar & R chart
  - Review the concepts of designed experiments, both full and fractional factorial
- Module 6 – Operational Qualification
- - Understand the purpose and role of Operational Qualification in Process Validation
  - Compare and contrast the FDA and GHTF definitions of Operational Qualification
  - State the source of production specification in the QSR
  - Describe challenge tests and their role in Operational Qualification
  - Explain how challenge tests can be related to designed experiments
- Module 7 – Performance Qualification
- - Understand the purpose and role of Performance Qualification in Process Validation
  - Compare and contrast the FDA and GHTF definitions of Performance Qualification
  - Explain how performance monitoring can be related to statistical control methods
  - Explain the role of action limits in performance monitoring
- Module 8 – Software Qualification
- - Understand the QSR and ISO 13485 requirements for software
  - State the QSR requirements for production software
  - State the ISO 13485 requirements for software used in production or service provision
  - Describe the requirement for software validation in embedded systems in production equipment
  - Part 11 requires validation of software used in electronic records or electronic signatures

Who Should Attend?

Individuals interested in learning how to conduct process validation, including engineers, managers, and project leaders.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

136A

Process and Software Validation

Contact for Schedule

Process and Software Validation

Course No. 136A

Duration:

14 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

137A

CAPA (Corrective and Preventive Actions)

Contact for Schedule

CAPA (Corrective and Preventive Actions)

Course No. 137A

Duration:

7 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

137B

Complaints & CAPA (Corrective and Preventive Action)

Contact for Schedule

Complaints & CAPA (Corrective and Preventive Action)

Course No. 137B

This course has been designed to learn CAPA (corrective and preventive action) system and its effective implementation and generate improved results.

Course Benefits

• Gain valuable strategies for getting information right away in the “golden hours” after the incident.
• Discover best practices for determining the real cause of human error with tools used by aviation accident investigators.
• Benchmark current best practices in CAPA and investigations with your peers.
• Learn practical strategies and techniques you can teach to all your employees.
• Obtain sample forms for conducting investigations and case reviews.
• Demonstrate to yourself the value of a cross-functional team and also ways that experts demonstrate their expertise
• Understand the four components of a well-written report and identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.

Prerequisites:

Quality background

Duration:

21 Hours / Contact for Schedule Days

Topics Covered:

CAPA - Introduction
- What Corrective Action/Preventive Action (CAPA) is
- The value of CAPA
- Differences - remedial action, preventive action and continuous improvement
CAPA – Writing Requests
- How to Properly Write a CAPA Request
- Information that is included in a CAPA request
- Benefits of a well-written CAPA (moves the process forward, etc.)
CAPA implementation
Root Cause Analysis
- Definition
- Nonconformity
- Root Cause – tools
- Reliable quality records
- Connection: root cause analysis and CAPA plan development
Action Plan
- Steps to take
- Identification of various activities and communications
- Functions: linkage
- Plan - acceptance
Follow-up
- Purpose
- Implementation - verification
- Effectiveness - verification
ISO 9001: 2008

Who Should Attend?

The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance/regulatory affairs, manufacturing (operations).

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

357

ISO 22000 Food Safety Management System

Contact for Schedule

ISO 22000 Food Safety Management System

Course No. 357

This course has been designed to provide an overview to develop and implement food services standard ISO 22,000. This standard applies to both large and small food providers and the requirements for both types of businesses.

Course Benefits

Participants will understand how to design, document and implement ISO 22,000. The management processes are to deliver the best possible quality to meet a customer’s business needs with agreed resource levels. Quality will be professional, cost-effective and with risks which are understood and managed.

Prerequisites:

None

Duration:

14 Hours / Contact for Schedule Days

Topics Covered:

ISO 9000 & ISO 22000:2005
Food Safety Systems
Certification, Registration and Accreditation
Food Safety Procedures
Food Safety Manual
Management Responsibility
Planning & Realization of Safe Products
Validation, Verification, and Improvement of the Food Safety Management System
Document Control
Food Safety Records
Competence, Awareness & Training
Prerequisite Programs
Hazard Analysis Preparation
HACCP Plan Management
Purchasing
Supplier Evaluation
Receiving & Inspection
Manufacturing
Identification, Labeling & Traceability
Control of Monitoring & Measuring
Control of Potentially Unsafe Food Product
Internal Audit & System Validation
Corrective Action
Continual Improvement
Product Recall
Emergency Preparedness & Response

Who Should Attend?

Food quality professionals who want to improve their FSMS or implement ISO 22000.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

360

EU-MDR

Mar 25-27

EU-MDR

Course No. 360

This course has been designed to understand European directives, CE marking and guidance documentation.

Course Benefits

Participants will understand EU directives and related directives (objectives, history, structure, purpose).

Duration:

21 Hours / Mar 25-27 Days

Topics Covered:

Who Should Attend?

The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), medical device manufacturers who desire to export to Europe.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

361

Design Control: Understanding, Implementation, and Improvement

March 4, May 11

Design Control: Understanding, Implementation, and Improvement

Course No. 361

This course has been designed to learn design control, design verification, design validation, Design History File (DHF), use concepts and implement, learn about planning (inputs/outputs), and risk analysis to ensure your organization\'s devices meet intended uses / user needs and specified requirements. Learn about control of design changes and their results as well as transfer (design to product manufacturing).

Course Benefits

Participants will understand FDA, design control, the life cycle of the product, the Design History File (DHF) and Device Master Record (DMR).

Prerequisites:

Medical Device background, those in quality / regulatory affairs responsible for design control.

Duration:

7 Hours / March 4, May 11 Days

Topics Covered:

Control of design in the Medical Device Industry
Design control process elements
ISO 9001vsISO 13485
The Design Control Team
Techniques for Design Verification & Validation
QSR
FDA Warning Letters related to design control
The content of design history file (DHF) & Device Master Record (DMR)
Process Model – approach to design control
Project Management: product life cycle in relation to design control
Exercises

Who Should Attend?

The target audience for this course consists of managers and professionals work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), or engineering (design).

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

362

GMP/ISO System Documentation

Mar 11-14

GMP/ISO System Documentation

Course No. 362

This course has been designed to learn add value to your company’s QMS by effectively and efficiently deploying GMP/ISO documentation (required documents, levels, etc.)

Course Benefits

Participants will understand ISO documentation, its requirements, process mapping / flowcharting, and Standard operating procedures (SOPs) / System-level procedures (SLPs).

Learning Objectives:
After completion of the course, student will be able to:
1. Articulate GMP and ISO 13485 requirements
2. Determine how GMP and ISO impact the organization for documentation and records maintenance
3. Examine each requirement of GMP and ISO 13485 to understand objective evidence needed
4. Execute processes and procedures to meet the standard requirements
5. Judge documentation and identify gaps in the Quality Management System (QMS)
6. Measure quality system performance and identify nonconformances and observations
7. Prepare QMS audit and system performance reports to identify QMS effectiveness
8. Conduct audits using process audit techniques
9. Implement QMS for registration

Prerequisites:

GMP / ISO background. Technology or Equipment Required Access to use of computer and internet. All courses are instructor-driven and provided via online or in-person. Course Requirements: To attain a certificate, attendees must pass the examination, (earn a passing grade) in course assessments, and meet all prescribed professional requirements of attendance, participation, homework and learning objectives. Projects, class activities, workshop and brainstorming will be covered in the class. Any homework given is required to be completed before course end.

Duration:

21 Hours / Mar 11-14 Days

Instructor:

The instructor will be a Certified Quality Auditor with 15 years’ experience

Who Should Attend?

The target audience for this course consists of quality, engineering and manufacturing who are involved in the development, implementation and use of GMP / ISO Documentation.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

362B

Certified GMP Professional (CGMP)

Contact for Schedule

Certified GMP Professional (CGMP)

Course No. 362B

Prerequisites:

None

Duration:

7 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

362C

GMP Compliance, Regulatory Affairs & Validation

Contact for Schedule

GMP Compliance, Regulatory Affairs & Validation

Course No. 362C

Duration:

28 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

363

QSIT- Quality System Inspection Technique

Contact for Schedule

QSIT- Quality System Inspection Technique

Course No. 363

This course has been designed to understand the FDA QSIT. Learn the inspection process, what FDA investigators will look at, and specific subsystems of management / design controls, production / process controls (P&PC), and corrective / preventive actions (CAPA).

Course Benefits

Participants will understand the FDA and its relationship to QSIT (Quality System Inspection Technique) and the inspection process.

Prerequisites:

Medical Device background, those in quality / regulatory affairs, those that work directly with FDA / inspections, those interested in FDA Quality System Inspection Technique (QSIT).

Duration:

14 Hours / Contact for Schedule Days

Topics Covered:

Module 1 – Legal and Regulatory Organization
- Understand the structure of US laws and regulations pertaining to medical devices and their implementation
- Describe the history of the Food, Drug, and Cosmetics Act
- Distinguish between citations of law and regulations
- Distinguish between FDA guidance documents and FDA recognized consensus standards
- Describe important definitions related to devices
- Recognize the FDA Centers and their role in device regulation
- Describe the role of inspection and the QSIT in FDA compliance activities
Module 2 – Management Controls
- Understand the responsibilities and authorities of top management and the Management Representative in the Quality System Regulation including Management Review and Quality System Audit.
- Compare and contrast the FDA’s QSR with ISO 13485 and historical versions of ISO 9001
- Recognize there are rare instances when QSR is not required for a medical device
- Understand the definition and role of the quality policy
- Understand the definition of “management with executive responsibility” and their authority and responsibility
- Understand the requirements for conducting management reviews and the expected review frequency
- Understand the requirement for a written quality plan and the expected contents
- Understand the requirement for procedures and instructions
- Understand the definition of quality audit and the requirements to conduct audits and re-audits
Module 3 – Design Controls
- Understand the requirements and records for medical device design, including risk management and software validation.
- Explain which devices are subject to design control
- List the requirements for design and development planning
- Understand design input including intended use and including patient and user needs
- Compare and contrast design input and design output, showing how they are related
- Compare and contrast design verification and design validation
- Identify when software validation is appropriate for device design
- Identify when risk analysis is appropriate for device design
- Describe the role of design transfer
- Understand the requirements for design changes including potential 510(k) revisions
- Describe the contents of the design history file
Module 4 – Corrective and Preventive Actions
- Understand the difference between correction, corrective action, and preventive action and explain how they apply to medical devices.
- Compare and contrast correction and corrective action
- Compare and contrast corrective action and preventive action
- Describe the analysis of quality data to identify existing and potential causes of nonconformities
- List some appropriate statistical methods for quality data analysis
- Explain the role of validation in the CAPA system
- Explain the role of verification in the CAPA system
- State the requirements to disseminate information about corrective and preventive actions
Module 5 – Production and Process Controls
- Understand the requirements for production processes applied to medical devices, including purchasing, process validation, and control of nonconforming material.
- Describe the four items required for a manufacturer to evaluate suppliers, contractors, and consultants
- Identify the document control requirements for purchasing data
- Describe the five essential items required when process controls are necessary
- Describe the requirements for production and process changes
- State the requirements for environmental controls when they are necessary
- State the requirements for personnel, including maintenance personnel
- State the requirements for contamination control
- State the requirements for production equipment including maintenance and inspection of maintenance
- Define manufacturing material and its control
- Identify automated processes and state the associated validation requirements
- State the requirements for IM&TE, including calibration and associated records
- State when a process must be validated and associated requirements
- Compare and contrast the types of acceptance activities
- Define the requirements to indicate acceptance status
- Compare and contrast correction and corrective action
- Compare and contrast repair, rework, and regrade
Module 6 – Facility and Equipment Controls
- Understand that sterilization process always require validation. Otherwise, they have the same requirements as Production and Process Controls
- State why sterilization always requires process validation
- Explain the primary device specification for sterilization processes, the target Sterility Assurance Level (SAL)
- List the traditional methods of sterilization
- Explain the considerations in selecting a contract sterilizer
Module 7 – Sterilization Process Controls
- 70(c) Environmental control
- 70(e) Contamination control
- 70(f) Buildings
- 70(g) Equipment
- 72 Inspection, measuring, and test equipment
Module 8 – Records, Documents, and Change Controls
- Understand the requirements for material control including installation and servicing.
- State the material identification requirements
- State the conditions when traceability is required and resulting action to take
- Explain the requirements to handle device labels including clearance and inspection
- Recognize that device packaging and shipping container requirements are design inputs
- List the reasons to establish a handling system as part of QSR
- List the QSR requirements for storage
- List the required information in distribution records including control numbers
- Identify devices that require installation and the associated documentation requirements
- List the documentation requirements for a device that is serviced
- State the requirements for analysis of service reports
Module 9 – Material Controls
- Understand the requirements for records, including the DMR, DHR, QSR, and complaint files.
- State the requirements for initial issue of a document
- State the requirements for revision or change to a document
- State the requirements for the location and removal of documents
- State the record retention requirements for device records
- Compare and contrast the records that a manufacturer must supply to the FDA and the exempt records
- State the role of the Device Master Record (DMR)
- Explain the role of the Device History Record and its relationship to the Device Master Record (DHR)
- State the role of the Quality System Record (QSR)
- Explain the allocation of records among the DMR, DHR, and QSR
- State the definition of a complaint
- Explain the types of complaints that must be investigated
- Compare and contrast the MDR requirements with complaint handling requirements

Who Should Attend?

The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations, production, process, corrective / preventive actions).

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

367

Hazard Analysis Critical Control Point (HACCP)

Contact for Schedule

Hazard Analysis Critical Control Point (HACCP)

Course No. 367

This course has been designed to provide an understanding of HACCP (Hazard Analysis Critical Control Point).

Course Benefits

Participants will learn HACCP (Hazard Analysis Critical Control Point).

Prerequisites:

For those involved / have background knowledge in HACCP (support or implementation), food safety or quality management system

Duration:

14 Hours / Contact for Schedule Days

Topics Covered:

Introduction,
Terms / definitions
7 Principles of HACCP and successfully recognize them
HACCP – Management Systems Integration
HACCP Plan: Implementation & Maintenance
GMPs - Good manufacturing practices
Food safety – provisions
HACCP principle applications for food (meat, processed foods, beverages, etc.) and non-food (manufacturers of packaging goods, food additives, etc.)
Regulatory Issues - HACCP
Hazards - Identification / Control
Exercises & Workshop

Who Should Attend?

Food quality managers / professionals, food safety auditors / consultants who want to improve their FSMS with HACCP.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

367A

Implementing Safe Quality Food (SQF) Systems

Contact for Schedule

Implementing Safe Quality Food (SQF) Systems

Course No. 367A

Duration:

14 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

368

Internal Auditor- ISO 22000

Contact for Schedule

Internal Auditor- ISO 22000

Course No. 368

This course has been designed to provide an understanding on auditing to ISO 22000. Learn the types of audits, effective reporting and auditor responsibilities.

Course Benefits

Participants will understand how to audit, document and know auditor responsibilities. Knowledge of ISO 22000 is covered.

Prerequisites:

Background on food management safety system, ISO 22000 knowledge.

Duration:

14 Hours / Contact for Schedule Days

Topics Covered:

Introduction,
Auditor – Responsibility / Role
Principles & Practices
Types of Audits
Auditing: Internal Audit (Plan, Execute, Report, Record, Follow Up, Closure)
ISO 22000:2005 (basic concepts and key requirements
ISO 19011:2002 Definitions, Concepts, and Guidelines
Effective Reporting / Documentation
Food Safety Systems

Who Should Attend?

Food quality professionals who want to improve their FSMS or implement ISO 22000.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

369

Lead Internal Auditor- ISO 22000

Contact for Schedule

Lead Internal Auditor- ISO 22000

Course No. 369

This course has been designed to provide an understanding on auditing to ISO 22000. Learn the types of audits, effective reporting and auditor responsibilities.

Course Benefits

Participants will understand how to audit, document and know auditor responsibilities. Knowledge of ISO 22000 is covered.

Prerequisites:

Background on food management safety system, auditing, ISO 22000 knowledge.

Duration:

14 Hours / Contact for Schedule Days

Topics Covered:

Introduction,
Auditor – Responsibility / Role
Principles & Practices
Types of Audits
Auditing: Internal Audit (Plan, Execute, Report, Record, Follow Up, Closure)
Audit Practices
Conformance
Codex Alimentarius
ISO 22000:2005 (basic concepts and key requirements
ISO 19011:2002 Definitions, Concepts, and Guidelines
ISO/TS 22003:2007
Effective Reporting / Documentation
Report audit findings
Food Safety legislation (national & global)
Food Safety Systems

Who Should Attend?

Food quality professionals who audit, want to improve their FSMS, work with ISO 22000.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

373

Sampling- ANSI Z1.4 & Z1.9 & C=O

Contact for Schedule

Sampling- ANSI Z1.4 & Z1.9 & C=O

Course No. 373

Participants will understand, implement, and learn about acceptance sampling. Students will be able to compare Z1.4 and C=0 plans as well as understand Z1.9 methods. Professionals who are facing sampling issues in their companies should strongly consider taking this course.

Course Benefits

Participants will look at the underlying statistics of acceptance sampling. They will also learn how to set up an acceptance sampling system.

Prerequisites:

None

Duration:

21 Hours / Contact for Schedule Days

Topics Covered:

Introduction
Concepts
Deming’s All or Nothing Approach
Common Ideas
Attribute Sampling Plans
The Concepts of OC Curves
Understanding the meanings of AQL
Setting up Z1.4 for Single Sample Plans
Using Double and Multiple Sample Plans
Comparing Z1.4 and C=0 Plans
Variables Sampling Plans
The Concepts of OC Curves, AQL, RQL, etc.
Understanding the Normal Curve
The Principles of Variables Sampling
Z1.9 Methods

Instructor:

The instructor is Sampling ANSI Z1.4 & Z1.9 & C=0 expert with 10+ years of industry experience.

Who Should Attend?

Quality Managers, Manufacturers, Project Managers, and other professionals who look to improve acceptance sampling at the workplace.

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

378

Medical Device Single Audit Program (MDSAP) Training

Contact for Schedule

Medical Device Single Audit Program (MDSAP) Training

Course No. 378

Duration:

21 Hours / Contact for Schedule Days

For More Information:

Contact the Training Administrator training@qpsinc.com, Phone: (508) 786-0777

Note:

This course is also available for training onsite. A discount is available when 6 or more attendees enroll

Business Solutions Providers for Quality, Productivity and Performance Excellence

Experts in Lean Six Sigma, Management System, Supply Chain, Project Management and Professional Development

Please register in any one of three ways:

Online:

Please select the course you wish to register for. A page will open for you to provide us with your information. We will then email you to confirm your registration.

By Phone:

Please feel free to call for your registration 508-786-0777. Our office hours are 8:30 a.m. to 4:30 p.m., Monday–Friday, Eastern Time.

Email:

Email our Operations Manager at training@qpsinc.com to register for any course.