home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

Webinar on Robust Verification and Validation

 
  July 18, 2014  
     
 


Compliance Trainings, Canada
July 30, 2014


This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.

And now the FDA is taking an even tougher stance

Why do companies need robust V&V?

What are the "must have" elements from  the cGMPs?

How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?

How can these be integrated into the company's quality management system?

Areas Covered in the Session :

Robust Verification and Validation -- Recent Regulatory requirements.

The Master Validation Plan(s).

Individual Verification and Validation Plans and their execution.

Product Verfication & Validation.

Process and Equipment Verfication & Validation, including Software.

QMS V&V and 21 CFR Part 11.

When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents.

The 11 Elements of the FDA's Software V&V "Model".

Incorporate the Hazard Analysis / Risk Management tools of ISO 14971 and ICH Q9.

Avoid recent compliance problems.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their company's planning and execution of verification and validation. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

Senior management

Middle management

R&D

Engineering

Software

QA / RA

Manufacturing

Operators

Consultants

cGMP instructors

And all personnel involved in verification and/or validation planning, execution and documentation.

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299 

 

 
 
Organized by: Compliance Trainings
Invited Speakers:

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

 
Deadline for Abstracts: July 29, 2014
 
Registration:

For more enquiries contact us

Compliance Trainings

5939 CandleBrook Ct, 
Mississauga, ON L5V 2V5, Canada 
Customer Support : 4169154458
Email : support@compliancetrainings.com

To register this webinar visit

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.