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 3. 3-HOUR VIRTUAL SEMINAR ON MASTER VALIDATION PLAN – THE UNWRITTEN
    REQUIREMENTS


3-HOUR VIRTUAL SEMINAR ON MASTER VALIDATION PLAN – THE UNWRITTEN REQUIREMENTS

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FACULTY: JOHN E. LINCOLN 

Scheduled Date : August 17 2022

Scheduled Time : 11am -  2:00pm ET



Description

FDA Warning Letters and recent high-profile recalls indicate major cGMP
deficiencies in many companies. One major failing is lack of sufficient or
targeted risk-based company-wide V&V planning. Starting with a Master Validation
Plan, evaluating its elements against ISO 14971 hazard analysis / risk
management, allows development of meaningful product validations. The roles of
different V&V protocols.

How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents
per ASTM E2500, against a background of limited company resources (personnel,
budget, time). A matrix simplifies “as-product”, “in-product”, process, and
equipment, et al, software V&VT, assuring key FDA requirements are not
overlooked. 

What is the FDA definition of “risk based” and how is it documented in the V&V
test report. Additional recommended supporting systems / documentation. The QMS
/ CGMP and 21 CFR Part 11 must also be considered.

Why You Should Attend:

Verification and validation requirements have always been part of the US FDA’s
GMPs.However, with increasing technology, both industry and regulatory agencies
expectations have increased. Recent high-profile field problems indicate that
V&V activities are not planned or carried out as completely as expected, are not
documented in a top tier Master Validation Plan, and may not be fully utilizing
the power of current risk management tools, as identified in ISO 14971. 

The FDA / ICH Q-series provide valuable insights for all regulated industries,
not just pharma. The billions of dollars spent by industry annually for V&V are
not providing the product safety or efficacy seemingly promised. For most
companies, the fixes are not rocket-science, but proper up-front V&V planning
and execution, documented in a corporate MVP and implemented by other V&V
documents.

Areas Covered in the Session :

 * Verification or Validation – Recent regulatory expectations
 * The Master Validation Plan and its structure
 * Product Validation – how it differs from process / equipment V&V
 * Process / Equipment / Facility Validation including FDA’s recent guidance
 * When and How to use DQ, IQ, OQ, PQ, or their equivalents
 * How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
 * The 11 key documents for software validation
 * Incorporating 21 CFR Part 11 requirements
 * Suggested “test case” formats
 * Approximately two 10 minute breaks during the webinar, with Q&A

Who Should Attend:

 * Quality Assurance Departments
 * Quality Control Departments
 * Research and Development Departments
 * Regulatory Affairs Departments
 * Manufacturing Departments
 * Engineering Departments
 * Operations Departments
 * Production Departments
 * Validation Departments
 * Compliance Departments
 * Documentation Departments
 * Software Validation Departments
 * Supplements Teams



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VIRTUAL SEMINAR VALIDATION UNWRITTEN REQUIREMENTS ISO 14971 John E. Lincoln FDA
Warning Letters
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QUALITY CONTROL LABORATORY COMPLIANCE - cGMP AND GLP TRAINING
ANALYTICAL INSTRUMENT QUALIFICATION & VALIDATION - USE OF EXCEL AND FDA AUDIT
PREPARATION
QUALITY & REGULATORY PATHWAYS FOR SAMD & AI DEVICES – ALL YOU NEED TO KNOW

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