Two Days Training on USFDA & Global Regulatory Audits

17th-18th April 2018 Mumbai

Course Description

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
 
For registration contact us on 9619046105 or 022-62210100 or email us on raj@marcepinc.com

Training Agenda

Current Regulatory Expectations & Real World ways to Succeed USFDA & Global Regulatory Audits

Two Days Training Agenda:

Day One
 
Session 1: Introductions to cGMP Investigations
Brain Storming and Interactive Session
Introduction to cGMP problems
Understanding Regulations related to Investigations and expectations
Importance of Investigations

Session 2: Out Of Specification Investigations
Importance of OOS investigation as per Regulations
Additional and Retesting Strategies
OOS results from Documentation and Reporting

Session 3: Root Cause Analysis tools and Case Studies
Root Cause Analysis, 5 Whys, Fishbone diagrams
Investigation Results Vs Batch Disposition Strategies
Hands-on approach and Step by step OOS Investigation Case Study

Session 4: Data Integrity and its Compliance
Introduction to Data Integrity and Pre-Requisites
ALCOA++++
Data Integrity Life Cycle Approach
Causes of Data Integrity
Where do we find problems with Data Integrity?
Regulatory Expectations for Data Integrity
Real Examples of Data Integrity Issues.
 
Day Two

Session 5: CAPA
What is CAPA? Steps in CAPA
Remedial action vs. CAPA
Corrective Action
Preventive Action
CAPA Team
CAPA Trending, Monitoring and Effectiveness checking

Session 6: FDA Observations case studies
Case Studies

Session 7: Incident and Deviations Investigations
Components of Deviations and Incidents
Handling and resolution of Deviations

Session 8: Written assessment and Question and Answer session
Summary and Wrap up
 
For registration contact us on 9619046105 or 022-62210100 or email us on raj@marcepinc.com
 

Course Director

Master of Science in Pharmaceutical Chemistry from BITS. Pilani. With decades of experience In pharmaceutical industry having held positions various levels of responsibilities to comply with the regulatory requirements (MHRA, FDA etc.) in following areas like Quality Control Testing, Analytical Method Validation, Stability Studies, GLP Compliance, Quality Management System Implementation, Quality System Audits (GAP Analysis) and Trainings. Worked with lots of Pharma Companies like Cipla limited; Wockhardt; Micro Labs; Dr. Reddy's Labs etc. Expertise in Investigation of out of Speci cation (OOS)/ Out of trend (OOT) results and provides scientifically justified corrective and preventive actions. Provides technical inputs to ensure Data Integrity systems in QC & ARD laboratories. Development and implementation of laboratory controls to meet the GLP, 21CFR PART 11, Electronic Records Maintenance requirements. Assist/ Manage continues support for laboratory inspection readiness activities. Knowledge and experience to provide solutions/corrective actions for non- compliances issued by various regulatory bodies (Ex: FDA 483's, NOC from WHO....etc.) Having In-depth Knowledge in Investigation of Analytical Incidences. Perform quality systems audits of Pharmaceutical Formulations, Biotechnology and API facilities and many more...
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