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: [email protected]

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WHEN AND WHERE

09 November 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Education , Health , Higher Education , Medical ethics