Data Integrity: FDA/EMA Requirements and Implementation training seminars presented by ComplianceOnline register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

Data Integrity: FDA/EMA Requirements and Implementation  

 Email information about this seminar Data Integrity: FDA/EMA Requirements and Implementation by ComplianceOnline to yourself your manager or associates Email this event... View and register for other training seminars like Data Integrity: FDA/EMA Requirements and Implementation by ComplianceOnline on FindaSeminar.com Find similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

Senior Quality and Regulatory Affairs managers,Clinical and Manufacturing Quality professionals,Regulatory Affairs professionals,Compliance professionals,In House Legal Counsel,Production supervisors,Manufacturing personnel,Production personnel,Laboratory Managers,Clinical Operations Personnel,Drug Safety (Pharmacovigilance) Personnel,R&D and Quality Control Scientists,Quality auditors

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

pharma+data+integrity+GMP+GCP+GLP+FDA+EMA+TGA+regulations+data+acquisition+ALCOA+Generic+Drug+Scandal+GXP+operations+audit+trails+computer+system+controls+PIC%2FS training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Data Integrity: FDA/EMA Requirements and Implementation seminar

 

 

Training Course Syllabus:


Learning Objectives:


Upon completing this course participants should:



  • Understand the meaning of the term “data integrity” and the importance of the acronym “A.L.C.O.A.” to regulatory agencies

  • Understand the difference between innocent lapses and deliberate wrongful conduct

  • Be aware of some of the key historical events that form the basis for regulators’ concerns about data integrity

  • Understand some of the common motivations for deliberate wrongful conduct that results in data falsification

  • Understand the impact of the use of computer systems on the maintenance of data integrity, and what types of system controls are mandated by various agencies around the world

  • Be aware of the possible business and regulatory consequences of noncompliance

  • Understand the important steps to take to prevent, detect and react to data integrity problems


Seminar Summary:

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. (see full course description)

print this agenda print agenda for the Data Integrity: FDA/EMA Requirements and Implementation training seminar

 view dates and locations for this seminar

 

 

 

Custom Search