We will soon announce the new 2026 training dates!!!
For additional information or questions about our courses, Call us! (787) 827-8028 or send us an email to info@eqvalpr.com
2025 Second Semester Courses:
Facilities and Utilities Qualification Process (Validations)
A two (2) full days course!
Obtain knowledge in the design, testing, monitoring and qualification requirements of Pharmaceutical and Medical Devices facilities and utilities.
Expected Audience:
- Professionals who want to expand their knowledge into the regulated industry facilities and utilities qualification process.
- Professionals whose performance or decision making can improve by understanding design, testing and qualification requirements.
Course Objectives:
- Get Knowledge in FDA design requirements and its Risk Base Approach for GMP Systems.
- Learn about applicable ISO Standards for Clean Rooms design.
- Understand ISO air cleanliness requirements, including testing and Environmental Monitoring Program requirements.
- Understand ISPE Qualification Guidelines, including qualification approach and the deliverables of the qualification process.
- Learn through experience... many, many samples of Direct, Indirect and No-Impact Systems (HVAC, Purified Water, Gases, BAS, etc.)
Two (2) days Course!
Saturday, 2 & 9 August, 2025
ADDITIONAL SECTION: Saturday, 6 & 13 September, 2025
(8:30 am - 4:30 pm) (14 hours)
Cost: $480*
Process Validation for Medical Devices
A two (2) full days course!
Expected Audience:
- Already with some experience working in the FDA-regulated industry, although not related to Process Validation?
- Already started doing ‘process validation’, but unsure about the process and the applicable validation regulatory requirements?
- Already performing validation activities, but want to expand your knowledge on validation protocols development and execution strategies, including ‘tips and tricks’?
- If you answered YES to any question above, this course is for YOU!
Course Objectives:
- Understand FDA guidelines and expectations for Process Validation (cGMPs, 21CFR Part 820, ISO 13485).
- Get advanced knowledge on Medical Devices Process Validation methodologies.
- Expand your knowledge on how to conduct and document validation activities, including validation protocols development and execution strategies.
Two (2) days Course!
Saturday, 16 & 13 August, 2025
ADDITIONAL SECTION: Saturday, 4 & 11 October, 2025
(8:30 am - 4:30 pm) (14 hours)
Cost: $480*
Lean Manufacturing: Process Improvement Tools
A two (2) full days course!
Expected Audience:
- Manufacturing professionals aiming to enhance productivity and efficiency in their operations, and responsible for streamlining processes and reducing waste.
- Quality Control personnel seeking to reduce defects and improve product quality.
- Supply Chain personnel focused on optimizing the flow of materials and information. Healthcare professionals looking to improve patient care and operational efficiency.
- Business consultants who want to incorporate Lean methodologies into their client solutions.
Course Objectives:
- Implement Lean Tools: Acquire practical skills in using Lean tools and techniques, such as 5S, Kanban, Just-In-Time (JIT), and Total Productive Maintenance (TPM) to enhance productivity and efficiency.
- Create Value Stream Maps: Develop the ability to create and analyze value stream maps to visualize and improve the flow of materials and information in production processes.
- Lead Lean Projects: Gain knowledge and leadership skills to initiate, manage, and sustain. Lean projects within their organizations or academic settings.
- Apply Lean in Diverse Industries: Learn how to adapt and apply Lean methodologies across various industries, including manufacturing, healthcare, and service sectors.
Two (2) days Course!
Saturday, 6 & 13 August, 2025
(8:30 am - 4:30 pm) (14 hours)
Cost: $480*
Computer System Validation (CSV) for the FDA Regulated Industry
A two (2) full days course!
Expected Audience:
- Experienced with the fundamentals of process validation and equipment qualification within the FDA regulated industry.
- Professionals who want to expand their validation knowledge into the computer system validation (CSV) process.
- Professionals who already started doing ‘computer system validation’ but are unsure about the different CSV methodologies and the applicable validation regulatory requirements.
- Professionals who already perform CSV activities but want to expand their knowledge on 'System Development Life Cycle' as a methodology.
Course Objectives:
- Learn the FDA regulatory requirements applicable to Computer System Validation (Electronic Records/Electronic Signatures/Data Integrity)
- Understand the importance of computerized systems and automated equipment validation within the field of manufacturing operations.
- Differentiate between Computer System Validation and Software Validation
- Distinguish between ‘Closed’ and ‘Open’ Computerized Systems Familiarize with the ISPE’s Good Automated Manufacturing Practices (GAMP) guide for validation of automated systems.
- Understand the difference between GAMP Software Categories and the validation approach for each one of them.
- Familiarize with the System Development Life Cycle (SDLC) Methodology and how to use it for CSV Projects.
- Understand the SDLC phases, its purpose, and the ‘what’ and ‘how’ to execute on each phase.
- CSV protocols (i.e. VP, IQ, OQ, PQ) applicable test cases development and execution discussion (samples discussion or bring your own case!)
Two (2) Days Course!
Saturday, 20 & 27 September, 2025
(8:30 am - 4:30 pm) (14 hours)
Cost: $480*
Understanding the Pharmaceutical and Medical Devices Validation Process
An introductory course!
Expected Audience:
- College students looking for understanding of the pharmaceutical and medical devices validation process.
- Professionals from other industries who want to expand their knowledge into the pharmaceutical and medical devices manufacturing industry.
- Professionals from both industries whose performance or decision making can be improved by understanding the validation process.
Course Objectives:
- Get knowledge on the fundamentals of the Pharmaceutical and Medical Devices industries validation process.
- Learn the FDA and ISO guidelines and expectations for validations.
- Differentiate between verification, validation and qualification.
- When to validate? Identify when validations are required.
- Learn about Validation Master Plans and how it helps the validation planning process.
- Learn how to conduct and document validation activities, including validation protocols (IQ, OQ, PQ) development and execution.
First Section: Three (3) Days Course!
Monday 22, Tuesday 23, & Thursday 25, September, 2025
(6:15 pm - 9:45 pm) (10.50 hours)
Second Section: Two (2) Days Course!
Saturday, October 25, & November 1, 2025
(8:30am- 4:30pm-8:30am- 12:30pm)
Cost: $360** enrolled college students cost is $280
CAPA System: Investigation & Documentation Process
A two (2) full days course!
Expected Audience:
- Already with some experience working in the FDA-regulated industry, although not related to CAPA System?
- Already doing investigations, but unsure about the process and the applicable regulatory requirements?
- Already performing CAPA Investigations, but want to expand your knowledge on the investigation process and root cause analysis tools?
If you answered YES to any question above, this course is for You!
Objective:
- Understand FDA guidelines and expectations for conducting CAPA investigations (cGMPs, 21CFR Part 820, ISO 13485)
- Get advanced knowledge on investigation and root cause analysis methodologies.
- Learn the importance of the identification of true root causes and CAPA plan.
- Expand your knowledge on how to conduct and document CAPA Investigations.
Two (2) Days Course!
Saturday 11 & 18, October, 2025
(8:30am - 4:30pm) (14 hours)
Cost: $480*
Understanding Manufacturing Quality Systems: Corrective & Preventive Actions (CAPA)
An introductory course!
Expected Audience:
- College students looking for understanding of the Corrective and Preventive Action Process in the pharmaceutical and medical devices industries.
- Professionals from other industries who want to expand their knowledge into the pharmaceutical and medical devices manufacturing industry.
- Professionals from both industries whose performance or decision making can be improved by understanding the CAPA process.
Course Objectives:
- Get knowledge on the fundamentals of the CAPA System in the Pharmaceutical and Medical Devices industries.
- Learn the FDA and ISO guidelines and expectations for CAPA System.
- Differentiate between correction, corrective action and preventive action.
- How to determine root causes.
- Learn about how to perform investigations, root cause analysis and corrective and preventive action identification.
Two (2) Days Course!
Saturday, 1 & 8 November, 2025
(1:00 pm - 4:30 pm/ 8:30am - 4:30pm) (11 hours)
Cost: $360* enrolled college students cost is $280
Lean Manufacturing: Understanding the Key Principles
An introductory course!
Expected Audience:
- Engineering students with a focus on Industrial, or interest to work or service in manufacturing companies.
- Business students interested in operations management or supply chain management.
- Healthcare administration students looking to apply Lean principles to improve healthcare services.
Course Objectives:
- Understand Lean Principles: Gain a comprehensive understanding of the core principles and concepts of Lean manufacturing, including the elimination of waste, continuous improvement (Kaizen), and value stream mapping.
- Identify Waste: Learn to identify various types of waste (muda) in manufacturing processes, such as overproduction, waiting, transportation, excess inventory, motion, defects, and underutilization of talent.
- Implement Lean Tools: Acquire practical skills in using Lean tools and techniques, such as 5S, Kanban, Just-In-Time (JIT), and Total Productive Maintenance (TPM), to enhance productivity and efficiency.
- Enhance Quality: Understand the importance of quality control and how to implement Lean techniques to reduce defects and improve overall product and process quality.
- Apply Lean in Diverse Industries: Learn how to adapt and apply Lean methodologies across various industries, including manufacturing, healthcare, and service sectors.
Two (2) Days Course!
Saturday 15 & 22 , November 2025
(8:30 am - 12:30 pm / 8:30am - 4:30pm) (11 hours)
Cost: $360* enrolled college students cost is $280
Quality Engineering: Theories and Practices
Five (5) days training covering the ASQ 'Certified Quality Engineer' body of knowledge
- Continuous Improvement: (Lean, Six Sigma, CAPA, 7 basic quality tools) • Statistical Methods: (Hypothesis & ANOVA testing, Capability Indices, SPC, DOEs)
- Product & Process Design: (Design Input & Review, Validation & Verification, Reliability)
- Product & Process Control: (Acceptance Sampling, Metrology, MSA) • Management & Leadership: (Quality Philosophies, Leadership and Facilitation skills)
- Quality Systems: (QS elements, Quality standards, Cost of Quality)
- Risk Management: (Risk Oversight, Assessment and Control)
As part of this Course:
- Gain in-depth theoretical and practical knowledge in key Quality Engineering concepts
- Strong emphasis on statistics and continuous improvement methodologies
- Acquire the knowledge, tips and tricks to pass the CQE
Dates: Soon!
Five (5) Days Course!
(8:30am to 4:30pm)
Other courses available. Call us for more information!
