Introduction to Quality Matrices •What is Quality metrics Background&Glossary •Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements •Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages Legal authority •Records Associated with the Process Validation Lifecycle and PQS Assessment •Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection The Use of Quality Metrics and Effect of Non-Reporting •How FDA Intends to Use Quality Metrics •Effect of Non-Reporting Group Discussion: Implementing Trending of Quality Indices in Your Organization The importance of the right culture and people • Role of leadership in trending of Quality Indices • Developing anonline data base for Quality Indices •Analysis, interpretation and reporting of Quality Indices The Process Flow • Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices • Determining responsibilities and roles for the implementation of trending of Quality Indices Starting the Quality Indices Management Process •Review of Quality Indices and Gap evaluation •Preparation of Data bases for Data acquisition •Collection data for completeness and Accuracy •Processing and Reporting of Quality Metrics Day Two Reporting of Quality data and Calculation of Quality Metrics • Who Reports and Who May Contribute to the Report • Quality Metrics that FDA Intends to Calculate • What Quality Data Would Be Reported • How to Report Quality Data to FDA Instructions for Quality Metric Data Submission •Worksheet for Data Tables •Product Specific Information •Mandatory Data •ICH Q9 •Optional Metrics Recognizing and Understanding the Trending of Quality Indices Working Session, I: •Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis Working Session II: •Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class. Complexities of Implementation Quality Metrics •Overcoming the pitfalls •Benefits and Risks General Discussion and Questions

1. Application Of Quality Metrics In Determining Overall State Of Quality
& The Health Of Associated PQS
“FDA’s Current Thinking”
Greater visibility and transparency between industry and regulators
• Ability to identify drifts earlier to drive audit/ inspection schedules
• Risk based approach to inspections
• Increasing consistency of metrics
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use
Complexities of Implementation (Industry Feedback)
What does it all mean?
• Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description [ICH Q9 / Definitions]
• Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
• Provides indication that controls are losing effectiveness
• Important in achieving problem resolution and problem prevention
• Another important concept of modern quality systems is the use of trending to examine processes as a
whole.
• Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
• Comparing data that is not consistently defined or comparison of single data values
• Using metrics as a quality “surrogate”
Training Benefits
Identifying Risks
Two Day Pharma Conclave:
th th
26 - 27 July 2016
Mumbai
th th
28 - 29 July 2016
Hyderabad
www.marcepinc.com info@marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
since: 1980
training the professionals
R

2. Introduction to Quality Matrices
Background & Glossary
Legal authority
The Use of Quality Metrics and Effect of Non-
Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your
Organization
The importance of the right culture and people
The Process Flow
Starting the Quality Indices Management Process
 What is Quality metrics
 Modernization of Regulatory Oversight of Drug
Quality and Promotion of Post-Approval
Improvements
 Use of Quality Metrics by FDA for Risk-Based
Inspection Scheduling and Prediction of Drug
Shortages
 Records Associated with the Process Validation
Lifecycle and PQS Assessment
 Authority to Inspect Records and Request in
Advance of or In Lieu of an Inspection
 How FDA Intends to Use Quality Metrics
 Effect of Non-Reporting
 Role of leadership in trending of Quality Indices
 Developing anonline data base for Quality Indices
 Analysis, interpretation and reporting of Quality
Indices
 Establishing the ground rules, procedures, forms
and mechanismfor data collection for Quality indices
 Determining responsibilities and roles for the
implementation of trending of Quality Indices
 Review of Quality Indices and Gap evaluation
 Preparation of Data bases for Data acquisition
 Collection data for completeness and Accuracy
 Processing and Reporting of Quality Metrics
Reporting of Quality data and Calculation of
Quality Metrics
Instructions for Quality Metric Data Submission
Recognizing and Understanding the Trending of
Quality Indices
Working Session, I:
Working Session II:
Complexities of Implementation Quality Metrics
General Discussion and Questions
 Who Reports and Who May Contribute to the
Report
 Quality Metrics that FDA Intends to Calculate
 What Quality Data Would Be Reported
 How to Report Quality Data to FDA
 Worksheet for Data Tables
 Product Specific Information
 Mandatory Data  ICH Q9
 Optional Metrics
 Participants will be divided into groups and given
acase study and be asked to perform a trend analysis
on a given data. Each group will present theresults of
its analysis
 Participants will be divided into groups and given
acase study and be asked to perform a trend analysis
and propose a Quality metric by using Risk Based
approach for the specific set of data. The results of
the analyses willbe shared in the class.
 Overcoming the pitfalls
 Benefits and Risks
Application Of Quality Metrics In Determining Overall State Of Quality
& The Health Of Associated PQS
“FDA’s Current Thinking”
Two Day Pharma Conclave:
www.marcepinc.com info@marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
since: 1980
training the professionals
R
th th
26 - 27 July 2016
Mumbai
th th
28 - 29 July 2016
Hyderabad
Two Day Training Modules:
Day- One Day- Two

3. Course Director:
He is a resourceful professional offering about 30 years of experience in executing Quality, Regulatory Affairs,
Audits & Compliance for green field projects for Pharma, Biotech plants & laboratory set up, expansion,
modernization, installation & amp; commissioning of manufacturing unit.
 Extensive hands on experience on all Injectable/ Parenteral Dosage Forms (Prefilled syringes/ Vials/
Lyophilized Vials/ Multidose pen), Solid Dosage forms and API 7 intermediate manufacturing.
 Directly responsible for cGMP compliance and strengthening of Quality Management systems & procedures
across the Organization including R&D.
 This includes Harmonization of systems & procedures, cGMP compliance, Corporate audits, Training, Audit
and compliance, design and execution, layout design and detailed engineering, validation of facility, water system,
equipment, method, process, cleaning validation, computer and electronic system validation, change control,
deviation, OOS, OOT, investigation, CAPA, maintenance and preventive maintenance, stability testing, quality
control, batch control and product release, media fill trials, documentation system, product recalls, internal quality
audit- self inspection, complaint handling, risk analysis, APQR, EM and water quality monitoring, cold chain and
shipper validation, Vendor qualification, implementation of IT systems like SAP, ERP, LIMS and electronic
documentation, knowledge sharing, designing of system according to various country specific regulatory
guidelines, including Regulatory updates, support for Regulatory audits etc. for Manufacturing sites.
 Have successfully faced several USFDA, MHRA, TGA, WHO-Geneva, ANVISA, audits and other MOH audits.
 Involved in Projects with respect to Quality assurance and automation in QMS.
 Extensive experience in developing and managing cross functional and multi- location teams/ activities
encompassing outsourced manufacturing, in- process QA, technology transfers and compliance to integrated
cGMP/ cGLP standards and setting up cost effective quality monitoring systems.
 Ensuring that teams adhere to robust quality standards & procedures through precision/ calibration and
monitoring sessions.
 An out of the box thinker with exceptional track record that demonstrates self- motivation, creativity, and
initiative to achieve corporate goals through interpersonal skills and team spirit.
Notable Accomplishments:
 First- hand experience in negotiating with US FDA, CHMP and MHRA.
 Author of Monographs for Indian and European Pharmacopoeia.
 Played a key role in installation new Analytical, Process Control and QA laboratories through capacity
calculation, design, budgeting, and procurement.
 International speaker on Quality, Regulatory & Risk Mgmt. aspects of pharma sector.
Having a work experience for Indian Pharma Giants:
Jubilant Life Sciences Ltd.
OmniActives Health Technologies Ltd. Pune
USV Ltd. Mumbai
ZydusCadila Healthcare Ltd, Ahmedabad
Intas Pharmaceuticals Ltd., Ahmedabad
Dr. Reddy's Lab Ltd., Hyderabad
B. V. Patel (PERD) Center, Ahmedabad
Nixcil Pharmaceutical Specialties Limited, Lucknow
Ph.D. (Chemistry) from Central Drug Research Institute, Lucknow
Dr. Nishodh Saxena PhD - Chem
Application Of Quality Metrics In Determining Overall State Of Quality
& The Health Of Associated PQS
“FDA’s Current Thinking”
Two Day Pharma Conclave:
www.marcepinc.com info@marcepinc.com Tel: 022- 30210100 Fax: 022- 30210103
th th
26 - 27 July 2016
Mumbai
th th
28 - 29 July 2016
Hyderabad

4. Application Of Quality Metrics In Determining Overall State Of Quality
& The Health Of Associated PQS
“FDA’s Current Thinking”
Delegate Registration Form:
th th
26 - 27 July 2016
Mumbai
th th
28 - 29 July 2016
Hyderabad
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Tel: 022- 30210100 Fax: 022- 30210103
info@marcepinc.com
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www.marcepinc.com
since: 1980
R
training the professionals