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.

1. Current Regulatory Expectations &
Real World ways to Succeed
USFDA & Global Regulatory Audits
th th
17 -18 April 2018
Mumbai
For delegate registration & enquiries contact us on: raj@marcepinc.com or Tel: +91- 22- 62210100
www.marcepinc.cominfo@marcepinc.com Cell: 9619046105
An ISO 9001:2015 CERTIFIED COMPANY
R
Pharmaceutical Training Workshop
GRA
2018
Why to 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 on 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. 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
The Course Director:
Mr. B H Koti Reddy

2. Day One
Brain Storming and Interactive Session
Introduction to cGMP problems
Understanding Regulations related to Investigations and expectations
Importance of Investigations
Importance of OOS investigation as per Regulations
Additional and Retesting Strategies
OOS results Documentation and Reporting
Root Cause Analysis, 5 Whys, Fishbone diagrams
Investigation Results Vs Batch Disposition Strategies
Hands on approach and Step by step OOS Investigation Case Study
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
What is CAPA? Steps in CAPA
Remedial action vs. CAPA
Corrective Action
Preventive Action
CAPA Team
CAPA Trending, Monitoring and Effectiveness checking
Case Studies
Components of Deviations and Incidents
Handling and resolution of Deviations
Summary and Wrap up
Session 1: Introductions to cGMP Investigations
Session 2: Out Of Specification Investigations
Session 3: Root Cause Analysis tools and Case Studies
Session 4: Data Integrity and its Compliance
Session 5: CAPA
Session 6: FDA Observations case studies
Session 7: Incident and Deviations Investigations
Session 8: Written assessment and Question and Answer session
Current Regulatory Expectations &
Real World ways to Succeed
USFDA & Global Regulatory Audits
Pharmaceutical Training Workshop
For delegate registration & enquiries contact us on: raj@marcepinc.com or Tel: +91- 22- 62210100
www.marcepinc.cominfo@marcepinc.com Cell: 9619046105
th th
17 -18 April 2018
Mumbai
The Training Agenda
GRA
2018

3. Current Regulatory Expectations &
Real World ways to Succeed
USFDA & Global Regulatory Audits
Pharmaceutical Training Workshop
th th
17 -18 April 2018
Mumbai
For delegate registration & enquiries contact us on: raj@marcepinc.com or Tel: +91- 22- 62210100
www.marcepinc.cominfo@marcepinc.com Cell: 9619046105
Mr. B H KOTI REDDY- 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. Wor ked 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...
The Course Director:
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 ...
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.
This Training primarily is in a lecture format through PPTs but includes practical case studies
Interaction and questions are encouraged to facilitate better understanding
Topics can be appropriately modified to fit your specific training objectives.
The Highlights:
The Regulatory Bodies:
The Workshop Coverage:The Workshop Coverage:
The Introduction:
GRA
2018
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.

4. Current Regulatory Expectations &
Real World ways to Succeed
USFDA & Global Regulatory Audits
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th th
17 -18 April 2018
Mumbai
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An ISO 9001:2015 CERTIFIED COMPANY
GRA
2018