Engineering, Quality and VALidations (EQVAL) Consulting Group, Inc.

• 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 improve 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

 Expected Audience:

• Professionals and college students with basic knowledge and understanding of the fundamentals of process validation within the FDA regulated industry (Biotech, Pharmaceutical, Medical Devices)
• Professionals already working in the FDA regulated industry, looking for a clear understanding of CSV and Data Inegrity concepts
• Professionals looking to expand their knowledge on the relationship between CSV and Data Integrity, as part of the 'current Good Manufacturing Practices (cGMP)'
  

Course Objectives:

• Get knowledge on the CSV and Data Integrity fundamentals as applicable to the FDA regulated industry
• Understand the relationship between CSV and Data Integrity
• Understand the cGMP requirements applicable to Data Integrity
• Learn the cGMP Data Integrity concepts...and its definitions
• Understand why Data Integrity is important to assure the safety, efficacy and quality of drugs
• When is CSV necessary? Is Data Integrity applicable? Identify when!
  
• Learn the FDA and 'Good Automation Manufacturing Practices (GAMP)' guidelines and expectations applicable to CSV
  
• Familiarize with 'System Development Life Cycle' as a CSV Methodology.
• Familiarize with CSV protocols (i.e. VP, IQ, OQ, PQ) applicable test cases

   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
• Learn the importance of the Validation Plan as a planning tool
  
• Expand your knowledge on how to conduct and document validation activities, including validation protocols development and execution strategies

• Continuous Improvement: (Lean, Six Sigma, CAPA,  7 basic quality tools)

• 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 exam

Dates:

Cost: $750*

* Company prices are $900

* Includes Certificate of Participation, ASQ training materials and snacks

*Payment plans and discounts available. Interested? Call for details!

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!)



Course Objectives:

• Understand the background of the lean methodology, including its purpose and benefits

• Define the core principles of lean and explain how value is defined

• Explain the concept of waste and identify sources of waste

• Familiarize with basic lean tools:  5S, Visual Management, Standardized Work, Kanban, Jidoka, Poka-yokes, PDCA and Kaizen

• Practical workshop to apply concepts discussed. Learn by working on it!

Dates:

Pending new sections for 2021!

Interested? Call for details!