Medical Writing Webinar

Medical Writing

Webinar Date: 25 FEB 2021 to 01 MAR 2021

Batch Timings: 04:00 PM to 05.30 PM IST

09:30 AM to 11:30 AM EST (US)

Programme Duration: 1.5 Hours

Days

Hours

Minutes

Seconds

Experienced professionals in Quality Assurance / Pharmacovigilance / Clinical Trail Operations / Medical writing / Clinical data Management / Clinical SAS Programmers / Regulatory Affairs
IT, QA, & Business Managers and Professionals who need to:

Manage or participate on computer system projects requiring validation.
Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
Understand the process of computer system validation.
Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meet the latest regulatory expectations.
Understand the FDA and international regulatory landscape around CSV.

GAMP 5
How to Manage Change and Configuration in Effective way
Calibration, Qualification and Validation
CFR part11 compliance
Annex 11
ALCOA+
GDP- Good Documentation Practices and ERES Practices.
Mastering Computer Systems Validation
483 –warning letter Response & Remediation
Risk Assessment and Management
Brief Details on Cloud Validation – IaaS, SaaS, PaaS, Types of Cloud, Importance of SLA
Periodic Review Protocol and Report (Reduce your revalidation work scientifically)
Good Check list to control Data Integrity
Eight habits of highly compliant Organizations
cGMP as per 21 CFR 211 Key points
GxP Work Flow
Data Life Cycle
Software Development Life Cycle
Vendor and Equipment Qualifications.
How to host Data Integrity Audit.
Three Process Flow Can help you control CSV in best possible way.
Black Box- White Box Validation
Legacy – Hybrid Systems
Open – Close Systems
Open Close – Culture
Software – Hardware Category as per GAMP5
Risk based work based on Novelty- Complexity and Critical Thinking
Static – Dynamic Data
Raw- Meta Data
Active – Passive Data
Analyses of One 483 – Warning letter
Good Remediation
Multiple Case studies
Role of FDA to 482-482-484-EUA
Type of inspection by FDA