TOPICS• Real-timereleasetestingfortheAPI• Idealcontentsofmanagement

reviewmeetingsformonitoringAPIperformance

• ContinuousprocessverificationforlegacyAPIs

• Recentregulatorytrendsandriskmanagement

• QbDforAPIs:ChallengesandOpportunities–aRoadMap

• Survivingglobalregulatoryinspectionsintoday’senvironment

• Outsourcingofregulatorystartingmaterials–changingregulatoryexpectations

INTERNATIONAL SPEAKERS - US FDA

Albinus D’saDeputyCountryDirectorUSFDAIndia

Jason D. RodriguezChemistUSFDA

PROGRAM CHAIRS

Shashank LulayConsultantQA&RA

Vijay Kshirsagar Consultant,TRACConsultingDirector,ISPE

KEYNOTE SPEAKER

Govind Rajan Narayanan ManagingDirectorAurobindoPharmaceuticals

Kiran Kumar PresidentInogentLaboratoriesPrivateLtd(AGVKBioCompany)

PROGRAM COMMITTEE

R. RaghunandananPharmaConsultantViceChair,ISPE

Nandkumar ChodankarDirectorASolutionPharmaceuticalPvt.Ltd.

Manikya Rao SeniorDirectorDr.Reddy’sLaboratories

Rajiv Desai President-QualityDishmanPharmaceuticalsandChemicalsLtd.

Kapil BhargavaFormerDeputyDrugControllerCDSCO

Gopal NairChairmanISPE

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PrOgram CHaIrs

1 | 1

Vijay Kshirsagar

Mr. Vijay Kshirsagar is a hard core Quality Assurance, Regulatory & Analytical professional with almost 39 years of rich experience of working for highly reputed Indian & Multinational Pharmaceutical firms. Till end April 2013, he worked for Unichem Laboratories Limited as Executive Vice President responsible for Corporate Quality, Regulatory & Analytical Research based in Mumbai for almost 7 years. He continues to be associated with Unichem even now but as Advisor. Prior to Unichem he worked for Ranbaxy Laboratories Limited as Director-Quality (Pharma) & also for Sun Pharma, Lupin, IPCA, German Remedies, Tata Pharma & Duphar Interfran. He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filing).

Vijay has led from front for successful completion of numerous regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, TGA etc. both for Drug Products & API’s. He has been instrumental in driving the filings of dossiers for various markets like US/EU/Brazil/Australia/SA & ROW including several ANDA’s/MAA’s/DMF’s/ASMF & CEP applications.

Mr Kshirsagar has been a frequent trainer in India & abroad through several platforms like ISPE, IDMA, IPA, CPHI, USP, PPS, SPDS etc. He has presented variety of topics related to cGMP, GLP, CV, AMV, Stability testing, Dissolution testing, Microbiological Validations, QbD, PAT, Aseptic Monitoring, Handling Regulatory Queries, Root Cause Analysis, CAPA, etc. He is currently working on the board of Directors of ISPE-India. He is also the President of ‘Society for Pharmaceutical Dissolution Science’ (SPDS). He has been conferred upon with an ‘Outstanding Analyst Award 2012’ by IDMA for his contribution towards pharmaceutical analysis. Mr. Kshirsagar has a Post Graduate degree in Organoanalytical Chemistry by Research, from Mumbai University.

Effective 1st May 2013, he has formed his own Pharma Consultancy called TRAC. As a consultant, now he is offering his services to various pharmaceutical companies in India and abroad for areas related to Training, Regulatory, Auditing & Compliance.

Shashank LulayConsultantQA&RA

Vijay Kshirsagar Consultant,TRACConsulting

Director,ISPE

All attendees will receive a Certificate of Attendance at the conclusion of the event.

In collaboration with:

LEARNING ObjECTIvES Attheconclusionofthisconferenceparticipantswillbeableto:• Updatethemselvesoncurrentqualityandregulatoryissues• Increasetheircompetitiveness• Equipthemselvestofilecorrectlyandefficiently• Understandthepotentialfocusofregulatorsduringtheirnextinspection• Understandandinterprettheregulatoryrequirementsinbuildingtherobust

processtechnologiesadheringtoQbD,ICHQ11etc.• Instillthecultureofbuilt-in‘quality’,reducingtherateoffailures,re-calls,

additionalcostandtimeoninvestigations,documentationandCAPA

WHO SHOULD ATTENDProfessionalsinvolvedin:• Qualityassurance• Qualitycontrol• Regulatoryaffairs• Processdevelopment• Technologytransfer/commercializationsourcing• Manufacturing

DIA-ISPE Joint Conference on API – Advantage IndiaBuilding a Sustainable and Regulatory Compliant API Life Cycle

ID#13653|August1-2,2013 NovotelConventionCenterHyderabad,India

In collaboration with:

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3.30-5.00 pm SeSSion3

3.30-4.15pm

Cleaning Validation - Conventional Process Discussions on the existing philosophy of Cleaning validation

Satya BalajiAssociate DirectorDr. Reddy’s Laboratories

4.15-5.00pm

Antony Raj GomesSenior vice President - QualityMylan Pharmaceuticals

5.00pm DayenD

DAY1| THURSDAY, AUGUST 1, 2013

9.15-9:45am openingCeremony Kaushik DesaiDirectorDIA India

Gopal Nair Chairman, ISPE

9.45-10.00am inaUgUraLaDDreSS V. G. Somanijoint Drugs Controller (I)CDSCO

10.00-10.30am KeynoteaDDreSSiGovind Rajan Narayanan Managing DirectorAurobindo Pharmaceuticals

10.30-11.00am KeynoteaDDreSSii

Kiran Kumar PresidentInogent Laboratories Private Ltd(A GvK bio Company)

11.00-11.30am teaBreaK

11.30am-12.30pmSeSSion1

11.30am-12.00pm

Changing Regulatory Expectations Current expectations of global regulators for APIs

Albinus D’saDeputy Country DirectorUS FDA India Office

12.00-12.30pm

Indian Scenario Current expectations of Indian regulators for APIs

Kodanda RamRegulatory ExpertAndhra Pradesh

12.30-1.30pm netWorKingLUnCH

1.30-3.00pm SeSSion2

1.30-2.15pm

ICH Q7 - Interpretations Made Easy Interpretations of different and important sections of Q7

Nandkumar Chodankar Director ASolution Pharmaceutical Pvt. Ltd.

2.15-3.00pm

ICH Q11-Challenges in Implementation Rajiv Desai President - QualityDishman Pharmaceuticals and Chemicals Ltd.

3.00-3.30pm teaBreaK

PROGRAM AGENDA

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To become a DIA member, go to www.diahome.org/membership.

Go to www.diahome.org/Community to join the Community of your choice.

3

DAY2| FRIDAY, AUGUST 2, 2013

9.30-10.15am SeSSion4

Discussion on the New EU Guidelines on Setting Health-based Exposure Limits

Ganesh PrasadConsultant

10.15-11.00am SeSSion5

API Monograph Development

Surendra NathSenior vice PresidentUSP

11.00-11.30am tea

11.30am-12.00pm SeSSion6

Process Validation New Concepts FDA Guidance 2011 on Pv

Sunil Singhaivice President, Tech. TransferDr. Reddy’s Laboratories

12.00-1.00pm SeSSion7

12.00-12.30pm

Cold Chain Management for APIs Good distribution practices for APIs needing cold chain

A. J. Reddyvice President - Supply ChainMylan Pharmaceuticals

12.30-1.00pm

Ravi MathurSenior Director and Head Logistics Dr. Reddy’s Laboratories

1.00-1.45pm netWorKingLUnCH

1.45-3.00pm SeSSion8

Rapid Screening Methods

Jason D. RodriguezChemist, US FDA

3.00-3.30pm teaBreaK

3.30-4.30pm SeSSion9

3.30-4.00pm

Quality Risk Assessment in API ManufacturingICH Q9 based discussion on APIs

Vijay Kshirsagar Consultant, TRAC ConsultingDirector, ISPE

4.00-4.30pm

Preparing for Regulatory Changes

Manikya Rao Senior DirectorDr. Reddy’s Laboratories

4.30-5.00pm Q&a

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register 10 from your company and receive the 11th free! Contact our group discount representative for details or call +91.98.2058.7798

PlEASE ConSIDER THIS FoRM AS An InvoICEDIA-ISPE Joint Conference on API – Advantage India

Building�a�Sustainable�and�Regulatory�Compliant�API�Life�CycleMeeting I.D. # 13653 | August 1-2, 2013 | novotel Convention Center, Hyderabad

NoNMEMBER MEMBER BASIC RATE (InR) SERvICE TAx

12.36%ToTAl (InR) BASIC RATE (InR) SERvICE TAx

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