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

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

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.