Good Documentation Guideline (Chapter 1029 USP)
About This Event
Overview:
This session will wrap up the general concept and will provide
information as to what needs to be documented in certain records.
Why should you Attend:
If you are involved in any product manufacturing, knowing GDP
regulations is a must for you. Manufacturing is prone to any kind of
errors, deviations, unforeseen events. It is of utmost importance to
know what you need to do in case of any unforeseen situations.
Areas Covered in the Session:
Laboratory records
Equipment-related documentation
Deviations and investigations
Batch records
Certificate of Analysis (C of A)*
Standard Operating Procedure (SOP)*
Protocols & reports*
Analytical procedures*
Training documentation
Retention of documents
Who Will Benefit:
Quality Assurance & Quality Control Personnel / Managers
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]