2019 - Complying with FDA's Good Documentation Practices [It Didn't Happen]
Date2019-08-13
Deadline2019-08-12
VenueFremont, USA - United States
KeywordsClinical and Manufacturing; Software Staff; Compliance trainings
Topics/Call fo Papers
Overview:
In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Why should you Attend:
As the FDA and TGA say "If it isn't written down, then it didn't happen". To meet industry standards, it is critical that all documentation follows GDP when it affects:
GMP /GLP /GCP processes
Material or product identity, quality, purity, strength and safety
Areas Covered in the Session:
Document Approval
Handwritten Entries
Copies of Documents
Document Maintenance
Document Modification
Warning Letters for GDocP
Who Will Benefit:
Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff
Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com
In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Why should you Attend:
As the FDA and TGA say "If it isn't written down, then it didn't happen". To meet industry standards, it is critical that all documentation follows GDP when it affects:
GMP /GLP /GCP processes
Material or product identity, quality, purity, strength and safety
Areas Covered in the Session:
Document Approval
Handwritten Entries
Copies of Documents
Document Maintenance
Document Modification
Warning Letters for GDocP
Who Will Benefit:
Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff
Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com
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Last modified: 2019-07-02 14:52:59