Record Keeping Best Practices [FDA and EMA] Documentation

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@compliance4All.com