Key Aspects of The Trial Master File And How to

May 14, 18 Key Aspects of The Trial Master File And How to

Key Aspects of The Trial Master File And How to Pass Fda Inspection – Webinar By Globalcompliancepan

With the growth of the Pharmaceutical and Biotechnology industry, audits get a lot more frequent. The complexity of the investigational items and of the medical trial protocols amplified the dangers for noncompliance. non-compliance in medical trials and misreporting of medical trial results that occurred within the last years produced the regulatory bodies to multiply the amount of audits. On the additional component, the sponsors also multiplied the audits from their component in the idea to attempt to downsize the chance of noncompliance through the trial.

The session will provide you with practical answers to get the best effects from an audit and the chance to grow the picture of your team and/or your website.

Areas Covered in the Program:

Who Will Benefit:

Calin Enea Popa, MD, CCRA may be the Founder and President of Advanced Clinical Study Assistance Inc. a Canadian full-service CRO that delivers CRO services and teaching to FDA and Wellness Canada regulated sectors. He provides ICH-GCP teaching and teaching for FDA and Wellness Canada rules. He provides consulting solutions for the intended purpose of compliance review, medication accountability, site management, protection review, training site staff, also to assure the integrity of medical data. Performed site audits and site audit planning. Conducted visits to teach new CRAs (sign-off appointments) and performs online teaching for CRAs and site personnel concerning regulatory compliance and Electronic Data Catch. He functions close with businesses and sites to get ready them for audits. He keeps the CCRA qualification from and can be an active person in the Association of Clinical Study Professionals.

Thursday, November 3, 201110:00 AM PDT 01:00 PM EDT GlobalCompliancePanel can be an online teaching gateway delivering top quality regulatory & compliance trainings in a straightforward, affordable and in a user-friendly format.

GlobalCompliancePanel offers a wide range of stations for broadcasting and exchange of info through online training, web alerts & dialogue forums.

GlobalCompliancePanel imparts understanding of guidelines in industry to ensure effective implementation of compliance applications for meeting regulatory needs. The key concentrate of GlobalCompliancePanel can be to provide intensive and quality teaching for risk administration, regulatory compliances, corporate governance and quality management. Aside from providing excellent teaching to compliance experts by compliance & consulting specialists, GlobalCompliancePanel would also concentrate on providing: