NERCSQA’s 2013 Spring Training: 1.5 GCP or GLP RQAP Re-Registration Units

Monday, June 17 2013
8:00 am – 4:30 pm

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

Receive 1.5 GCP or GLP RQAP re-registration units by attending NERCSQA’s 2013 Spring Training!
 
“Auditing Computer System Validations and Electronic Records”

Presented by: 

Chris Wubbolt, QACV Consulting, LLC
Binesh Prabhakar, Syner-G Pharma LLC

 
REGISTRATION INFORMATION:

NERCSQA Member    $200*
Nonmember (includes 1 year NERCSQA Membership)    $225*

*Government employees and full time students receive a 15% discount. Must provide proof of eligibility onsite to receive discount.

Breakfast and lunch will be provided

Register: Click here!

Registration deadline extended to Friday, June 14, 2013.

Directions: Click here

Please note: Parking is not included in the cost of registration.
 
AGENDA:
Time    Description
8:00 - 8:30 AM    Registration
8:30 - 9:00 AM    Introductions and Course Objectives
9:00 - 10:00 AM    Introduction to CSV and Electronic Recordkeeping Compliance
• Introduction to IT policies and SOPs
• 21 CFR Part 11
• Data integrity
10:00 - 10:15 AM    Break
10:15 - 11:00 AM    Audits - Planning
• Scheduling
• Scope
• Agenda
• Predicate rule review
• Electronic recordkeeping SOPs
11:00 AM - 12:00 PM    Audits – Execution
• System demonstration
• User requirements review
• Traceability analysis review
• Validation plan and report review
• Test documentation review
• Incident handling
• Electronic recordkeeping controls – administration, security, backup and restore, disaster recovery, etc.
12:00 - 1:00 PM    Lunch
1:00 - 2:30 PM    Audits – Execution (continued)
2:30 - 2:45 PM    Break
2:45 - 4:00 PM    Audits – Execution
• Reporting
• Continue audit execution discussion
• Reporting of audit results
• Audit follow up
• Example of an audit report
• Buckets of findings (minor, moderate, and major)
4:00 - 4:30 PM    Summary and wrap up
4:30 PM    Close
 
 

http://cmg.informz.net/CMG/archives/archive_3270892.html




 
 

Share MassBio

 

Janitronics

EvaluatePharma
 

MassBio