Global
CompliancePanel
Knowledge, a Way Forward…
2-day In-person Seminar:
Clinical Data Management Boston, MA July 26th & 27th, 2018 9:00 AM to 6:00 PM
Price Price:
$1,295.00
(Seminar for One Delegate)
Angela Bazigos CEO, Touchstone Technologies Silicon Valley
Register for 5 attendees
Price: $3,885.00 $6,475.00
You Save: $2,590.0 (40%)*
Seasoned Executive with 40 years of experience in the Life Sciences &
Register for 10 attendees
Healthcare Industries. Positions include Chief Compliance Officer
Price: $7,122.00 You Save: $5,828.0 (45%)* $12,950.00
http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773 095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/usingtraining-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
Clinical Data Management
2-day In-person Seminar:
Global
CompliancePanel
Clinical Data Management
Agenda: Day One
Day Two
Lecture 1 (90 Mins):
Lecture 1 (90 Mins):
CDM: The Reasons and The Requirements
Study Conduct
GIGO = Garbage In, Garbage Out. Why we need good
Data Entry
practices in data management Presentation and overview of FDA GCP Guidelines on
data management NIH Policy (SOP 15, 17, 19)
External Data integration and reconciliation Discrepancies, errors, corrections Data Cleaning (preparation) and Coding
21 CFR Parts 11, 312.62, 812.140,
Lecture 2 (90 Mins):
Lecture 2 (90 Mins):
Study Conduct (cont'd)
Elements in Developing a Data Management Plan
(MedDRA and WHODDE dictionaires)
Choosing vendors and outsourcing
Severe adverse events (SAE) status reporting
Data privacy and protection of subject data
Data Review and Quality Control
Quality Assurance and Quality Control
Data Transfer procedures
Monitoring and auditing of data
Lecture 3 (90 Mins):
Handling Errors and Corrections
Study Closeout
Storage and Transfer of Data
SAE Reconciliation
Lecture 3 (180 Mins; Afternoon of Day 1):
Quality Control
Study Startup
Database Lock
Essential documents
Electronic Archival
Prior to Study Commencement
Database Transfer
During Conduct of the Trial
Enhancing Reproducibility
After Completion/Termination of the Trial
Lecture 4 (90 Mins):
CRF design and development (paper/e-CRF)
Monitoring Visits
Database build and testing
What to expect during a monitoring visit
Edit Checks preparation and testing
Elements for Establishing a Corrective Action Plan Jeopardy Quiz - Clinical Data Management
2-day In-person Seminar:
Global
CompliancePanel
Clinical Data Management
What You will get
Group Participation
10%
2 Attendees to get offer
20%
3 to 6 Attendees to get offer
25% 30%
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Learning Objectives
2
Participation certiďŹ cates
3
Interactive sessions with the US expert
4
Post event email assistance to your queries.
5
Special price on future purchase of web
7 to 10 Attendees to get offer 10+ Attendees to get offer
Payment Option
based trainings.
1
Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link
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Special price on future consulting or expertise services.
2
Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216,
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GlobalCompliancePanel.
Fremont, CA 94539, USA
3
PO: Please drop an email to support@globalcompliancepanel.com or call the
4
Special price on future seminars by
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Seminar Kit – includes presentation handout,
our toll free +1-800-447-9407 for the invoice and
ID card, brochure, trainings catalog, notepad
you may fax the PO to 302 288 6884
and pen.
Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer
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Networking with industry's top notch professionals
information
Contact Information: Event Coordinator 161 Mission Falls Lane, Suite 216,
Kindly get in touch with us for any help or information.
Fremont, CA 94539, USA
Look forward to meeting you at the seminar
NetZealous LLC, DBA GlobalCompliancePanel
Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com
www.globalcompliancepanel.com
GlobalCompliancePanel