2018 - Record Keeping Best Practices [FDA and EMA] Documentation
Date2018-11-09
Deadline2018-11-08
VenueFremont, USA - United States
KeywordsGood Documentation; Best Practices; Validation Specialists
Topics/Call fo Papers
Overview:
Good documentation Practices (GDP) is an essential factor that needs to
be closely followed by the personnel in any regulated environment as a
process for a successful project completion including observations of
unanticipated responses that are required to be accurately recorded and
verified.
Why should you Attend:
If you are involved in any product manufacturing, knowing GDP
regulations is a must for you. It prevents a lot of errors and minimizes the
chance of being spotted by the regulatory bodies in their audits.
Areas Covered in the Session:
Definition, Purpose, and Importance
General Rules and Principles of GDP
Requirements of Records
General Tips in GDP
Signature / initial and the meaning
Copying records
Document maintenance
Who Will Benefit:
Laboratory Personnel / Managers
Validation Specialists
Clinical Trial Personnel
Project Managers
Speaker Profile:
Dr. Afsaneh Motamed Khorasani PhD is a Medical and scientific Affairs
expert and a Senior Scientist with a strong background in biomedical
science and clinical trial/research. She has a tenured and diverse range of
experience in medical affairs, basic and industrial clinical research and
development, clinical trials, Medical and regulatory writing and intellectual
property.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
Good documentation Practices (GDP) is an essential factor that needs to
be closely followed by the personnel in any regulated environment as a
process for a successful project completion including observations of
unanticipated responses that are required to be accurately recorded and
verified.
Why should you Attend:
If you are involved in any product manufacturing, knowing GDP
regulations is a must for you. It prevents a lot of errors and minimizes the
chance of being spotted by the regulatory bodies in their audits.
Areas Covered in the Session:
Definition, Purpose, and Importance
General Rules and Principles of GDP
Requirements of Records
General Tips in GDP
Signature / initial and the meaning
Copying records
Document maintenance
Who Will Benefit:
Laboratory Personnel / Managers
Validation Specialists
Clinical Trial Personnel
Project Managers
Speaker Profile:
Dr. Afsaneh Motamed Khorasani PhD is a Medical and scientific Affairs
expert and a Senior Scientist with a strong background in biomedical
science and clinical trial/research. She has a tenured and diverse range of
experience in medical affairs, basic and industrial clinical research and
development, clinical trials, Medical and regulatory writing and intellectual
property.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
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Last modified: 2018-09-07 16:02:10