USFDA & GLOBAL REGULATORY AUDITS

The Introduction: Recent Regulatory Audits focused on Data Integrity, Batch Failure Investigations, Deviations and effective management of Corrective and Preventive Actions (CAPA). The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Emphasis is placed by using practical, hands-on aspects of how to ensure Data integrity in routinely to facilitate root cause analysis. Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, trending problems and process monitoring team activities. This 2-day training session will update attendees on the latest in international regulatory requirements, guidance and best industry practices, present model case studies for improvement. The Workshop Coverage: This Training and workshop will cover cGMP Failures, Investigations, Root Cause Analysis, Corrective and Preventive Actions. Data Integrity advanced practical case studies and practical examples faced by Pharma industry today while facing highest regulatory requirements and expectations from US, Europe, and other regulatory authorities. The Regulatory Bodies: USFDA (USA), MHRA (UK), TGA (Australia), CDSCO (India), HEALTH CANADA (CANADA), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China), MEDSAFE (Newzeland), MHLW (Japan), SWISSMEDIC (Switzerland), are the few regulatory agencies and organizations ... The Highlights: This Training primarily is in a lecture format through PPTs but includes practical case studies Interaction and questions are encouraged to facilitate the better understanding Topics can be appropriately modified to fit your specific training objectives. Why attend this workshop? 01. To gain practical knowledge and implementation sound systems to failure investigations in cGMP environment. 02. Participants will explore various new strategies and latest trends in Failure Investigations. 03. Participants will find solutions to recent 483/Non compliances issued by various Regulatory Audits 04. Opportunity to meet Subject Matter Experts in cGMP Systems. 05. The better understanding of problem-solving techniques and CAPA 06. Documentation of failure investigation and Root cause analysis process 07. To get awareness of what the FDA looks in terms of Data integrity issues 08. Proactive steps to avoid Data integrity related form 483s and warning letters. 09. Discussion and solutions on recent FDA 483s and warning letters