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Webinar On A Robust Approach to Validation in Compliance with 21 CFR, Part 820.75

 
  April 15, 2015  
     
 


Compliance Trainings, Online
2015-04-23


Description :

Regardless or regulatory environment, United States or OUS, the validation of processes, which cannot be verified through inspection or test, is considered a salient requirement for medical device establishments. It is imperative that processes are capable of producing finished medical devices that are safe and effective in their intended use.

Failure to validate processes in accordance with §820.75 requirements is a frequently cited Form 483 observation in FDA warning letters. Device establishments either fail to validate their processes; or fail to validate their processes, with a high degree of assurance in accordance with established procedures. Remember, a manufacturing process that cannot be fully verified by subsequent inspection and testing is expected to be validated, to ensure the process continues to meet specifications as required by 21 CFR 820.75(a).

Areas Covered in the Session :

FDA requirements for validations

Understanding IQ, OQ, PQ, & PPQ

Scripting the validation protocol

Selecting confidence intervals

Training requirements

Equipment calibration requirements

Use of 3rd-party testing facilities to execute validations

Collection of validation data

The application of statistical analysis and documenting statistical rationale

Limit versus Challenge Conditions

Documenting deviations

Addressing validation failures

Documenting the requirement(s) for when to repeat validation

Who Will Benefit:

A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s validation studies. The staff who will benefit include:

Quality Professionals

Regulatory Professionals

Test Technicians

R & D Engineers

Manufacturing Engineers

Quality Engineers

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

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

 

 
 
Organized by: Compliance Trainings
Invited Speakers:

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

 
Deadline for Abstracts: 2015-04-23
 
Registration:

For more information about this event please visit

 

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1444

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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