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Webinar on FDA's Guidance on Process Validation for Drugs and Biologics

 
  April 15, 2016  
     
 


Compliance Trainings, Online
2016-04-27


Description :

Recent high-profile recalls and FDA warning letters recall the major cGMP deficiencies in pharma organizations and big name device. Now, FDA is up to take a tougher stance. A single major failing is a clear indicator of lack of target-based/sufficient process V&V execution/planning. Now, you need to consider FDA’s Process validation guidance documents and the ‘must have’ elements in them. You need ICH Q9 for hazards analysis and product/process risk management incorporation, and also need to integrate process validation essentials into quality management system of a company. Effective and real world process V&V is even more important when it comes to today’s industrial environment that is extremely resource constrained.

We will focus on US FDA documentation models in various applications that are field proven – including, ERP, wherever cGMP data/records are collected, used, stored and retrieved, and process/equipment and test/lab equipment control. The session will:

Address the U.S. FDA's key January 2011 Process Validation Guidance Document

Provide 3 key steps to process lifetime compliance

Discuss the FDA’s newer and tougher regulatory stance on V&V requirements

Review a company's Process Verification and Validation system for major cGMP deficiencies

One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Our V&V “model” simplifies process and equipment, et al, hardware and software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered.

Areas Covered in the Session :

The FDA’s Process V&V Guidance

Working toward homogeneity within and between batches – a key goal

The 3 Key / Lifecycle considerations

V&V Master Planning

Field-proven V&V “models” – useful for all V&V

Hardware and software V&V considerations

Developing test cases / scripts

“Risk Based”  -- what it means in V&V and how it should be used

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, devices, biologics and Combination Products fields. The employees who will benefit include:

Senior management

Quality Assurance

Reulatory Affairs

Engineering

Research & Development

Production

Operations

Consultants

 

All personnel tasked with product, process, validations and cGMP responsibilities

 
 
Organized by: Compliance Trainings
Invited Speakers:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 years as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.

 
Deadline for Abstracts: 2016-04-27
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1843

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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