India has become a priority location for the USFDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US. India with its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.50,000 crore of drugs in 2015-2016. 30% of this value being exported to the US alone, according to the Pharmaceutical Export Promotion Council of India. US FDA has increased the number of inspections at FDA approved units. The number of FDA 483 and warning letters , import alerts issued to pharmaceutical companies globally, have risen over the years and have been asked to review and strengthen its CAPA (Corrective Action Preventive Action) practices.

1. cGMPAUDITS&COMPLIANCE
AchievingQuality&ComplianceExcellenceinPharmaceuticalAudits
02nd - 03rd Dec. 2016
MUMBAI
05th - 06th Dec. 2016
CHANDIGARH
Course Faculty: G. Sundar: Best Documentation Award and Best PQ Award from Thermo Fischer Scientific –
USA (two Consecutive Years) for Clinigene International Limited.
since: 1980
R
training the professionals
cGMP
2016
We will be proud to become your in house training & business consultancy partner for your workforce & plant development.
For any tailor made training’s or consultancy at your facility in any industry vertical’s just email us on:
ortechsupport@marcepinc.com inhouse@marcepinc.com
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Maintainability & Reliability Certified Engineering Programs
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Register a team of 8 and pay for 5
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2. cGMP AUDITS & COMPLIANCE
Achieving Quality & Compliance Excellence in Pharmaceutical Audits
1. Introduction of CAPA
2. Triggering of CAPA from Audit observations
3. Types of CAPA
4. Fundamentals of Global cGMP Requirements-
Trends in cGMP Compliance
5. How to implement effective CAPA Systems-
Effective CAPA Management for Optimal
Compliance
6. Laboratory Compliance –Recent audit
observations and its CAPA
7. Behavioural GMPS (bGxP®): A New Paradigm in
Compliance Management
- Principles of CAPA
- Definition of CAPA
- Objectives of CAPA
- How Audit observations to be recorded
- How to document CAPA on audit observations
- CAPA format
- Correction
- Corrective Action
- Preventive Action
- cGMP Key requirements in USFDA and EU
- Inspections Requirements in USFDA/EU
- How to implement effective CAPA
- Effectiveness Verification of CAPA
- How to assess and to document Effective ness
verification
- What questions to be evaluated during effectiveness
verification of CAPA
- Recent Critical USFDA Laboratory QMS observations
- Recent critical EU laboratory audit observations
- How to rectify and effective CAPA on these
observations
- How to bring Compliance-cGMP environment
- Human behaviour issues and salvation techniques
- How to bring ethical cGMP compliance.
8. Spotting Overall Weak GMP Compliance Systems
9. CAPA –Failure Investigation and Root cause
analysis
10. Compliance Aspects of APIs Manufacturing
13. Compliance Aspects of Laboratory Quality
systems
14. Compliance Aspects of Sterile Manufacturing
13. How to face audits-National, International
regulatory Audits and Customer, Internal audits
14.Audit CAPA –Effectiveness Verification
15. CAPA-Closure
16. Avoiding FDA Enforcement Actions: An Optimal
and Sustainable Compliance Program
-Discussion on Current weakness in industry
-How to avoid weakness
-How to conduct failure Investigation on OOS,
Deviations, Market complaint, Laboratory incident,
Event failures and its Root cause analysis
-CAPA on failure investigations
-USFDA/EU requirements on API GMP Compliance
12 Compliance Aspects of Formulations Manufacturing
- USFDA/EU requirements on Formulation GMP
Compliance
- USFDA/EU requirements on laboratory Quality
systems Compliance
-Key Compliance requirements on sterile manufacturing.
- A motivation presentation and how to face, what to
answer, etc.
- How to check effectiveness of Audit compliance
- How to close Audit related CAPA
- How to implement robust Quality system to achieve
Optimal and Sustainable Compliance Program
Practical Work Shop:
1. How to address CAPA for Recent USFDA warning
letters/EU Non compliance observations
2. Regulatory Audits – Quality issues through case
studies
Q&A- Discussion section
Day One Day Two
02nd - 03rd Dec. 2016
MUMBAI
05th - 06th Dec. 2016
CHANDIGARH
cGMP
2016
Contact Us:
Tel: 022- 30210100 Fax: 022- 30210103www.marcepinc.com info@marcepinc.com

3. cGMP AUDITS & COMPLIANCE
Achieving Quality & Compliance Excellence in Pharmaceutical Audits
Background:
WhyAudit observation CAPA?
WealreadyhaveaCAPAsystem.Why should weattend?
Answers to all attendees questions:
India has become a priority location for the USFDAas it houses the largest number of FDA-approved drug manufacturing plants
outside the US. India with its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.50,000 crore of
drugs in 2015-2016. 30% of this value being exported to the US alone, according to the Pharmaceutical Export Promotion Council
of India.
US FDA has increased the number of inspections at FDA approved units. The number of FDA 483 and warning letters , import
alerts issued to pharmaceutical companies globally, have risen over the years and have been asked to review and strengthen its
CAPA(CorrectiveAction PreventiveAction)practices.
FDA and regulatory agencies are looking closely in how pharmaceutical companies conduct their investigations, and CAPA is
viewed as the central component of Quality Management Systems. Corrective and PreventiveAction (CAPA) is a key part of any
pharmaceutical quality program, and yet many companies continue to do it wrong (if FDA483 and Warning Letter reports are any
indicators).
CAPAprocess deficiencies have long been the number one Good Manufacturing Practice (GMP) violation cited in FDA483's and
WarningLettersforpharmacompanies.
The reason Audit observation CAPA has not been effective is because CAPA practices have not become a culture and not
percolated to the operator or plant level people. This workshop will focus on how aAudit compliance CAPAculture can be
createdin asystematicmannerso that CAPAispracticednot only in document but also in spiritofthe organization
Your organisation's non-conformances need to be addressed quickly and systematically. That is why you need to ensure your
management systems are equipped to document non-conformities efficiently, enabling you to tackle the issue as effectively as
possible. Our CAPA process training will provide you with the knowledge you need to ensure that your organization conducts
proper containment, correction and preventive actions.
He has developed his profile as Quality practitioner with multiple years of rich experience in the field of Quality Assurance,
QualityControl,BioequivalenceandPharmaceuticalRegulationsandRegistrations.
Worked with Leading National and International companies. His areas of expertise covers Pharmaceutical Quality Management
SystemsaspercGMP,GLP,GCPandasperRegulatoryagencieslikeEMA, USFDA, MHRAandMCC, TGA,ANVISA,
Japan; WHO Geneva and PIC(S) guidelines. Having a strong rich background on regulatory guidelines for ANDA, DMF, QbD;
CTDDocuments(ICH M 4Q) andBA/BEstudies.HandledregulatoryAuditsanditscompliancelikeUSFDA, UKMHRA,
WHO Geneva, DCGI-INDIA,TGAand EU PIC(S) stateAuthoritiesand prepareddocumentsfor compliance.Published articlesin
Society of quality assurance SQA, USA and also in national and international conferences. More than 22 publications in
International and national forums. Conducted nearly 500 trainings and specialist auditor for cGMP (both API and Formulations)
Clinical studies and BA/BE studies and GLPstudies. He has presented and got best appreciation for "cGMPon Data Integrity" and
compliance solutions at 12th Annual Meet -INDIA-AFRO-ASIA Pharma Business Meet-21st - 23rd Sep 2016 VENUE: Park
Hyattorganisedby PharmaceuticalsExportPromotionCouncilofIndia-pharmexcil-AGovtofIndiaprogramme
02nd - 03rd Dec. 2016
MUMBAI
05th - 06th Dec. 2016
CHANDIGARH
cGMP
2016
Course Director: G. Sundar
Contact Us:
Tel: 022- 30210100 Fax: 022- 30210103www.marcepinc.com info@marcepinc.com

4. Action is the real measure of intelligence
Napolean Hill
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since: 1980
training the professionals
R
Maintainability & Reliability Certified Engineering Programs
Contact Us:
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since: 1980
R
training the professionals
cGMP
2016cGMP AUDITS & COMPLIANCE
Achieving Quality & Compliance Excellence in Pharmaceutical Audits
02nd - 03rd Dec. 2016
MUMBAI
05th - 06th Dec. 2016
CHANDIGARH