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cGMP Audits and Compliance

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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.

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cGMP Audits and Compliance

  1. 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 Let’s make your assets safe & better ! www.marcepinc.com Maintainability & Reliability Certified Engineering Programs CORPORATE DISCOUNTS Register a team of 8 and pay for 5 Register a team of 6 and pay for 4 Register a team of 4 and pay for 3
  2. 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. 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. 4. Action is the real measure of intelligence Napolean Hill OUR MECHANICAL PRODUCTS: Your training partner is venturing into designing, manufacturing and distribution of Our collection is supported by strong after-sales services, and provides users with safety and environmental benefits. products’ have wide range of applications for We take pride in our ability to help our customers improve reliability, make a positive environmental impact and reduce operating expenses. One of our key strengths is our unmatched ability to deliver precision engineering products orders within of a customer's request. Parts & Services Repairs & Upgrades Field & Support Services Engineering Services Asset Performance Management Send your valuable queries by mail to our technical support team at: Any Customized Mechanical Products, Mechanical Seals, Tube Fittings as per ASME BPE Standards etc. Marcep Inc. Oil and Gas, Pharmaceutical, Chemical Processing, Pulp & Paper, Power Plants, FMCG, etc. 72 hours Services available 24×7 for our speciality products include: techsupport@marcepinc.com since: 1980 training the professionals R Maintainability & Reliability Certified Engineering Programs Contact Us: Tel: 022- 30210100 Fax: 022- 30210103www.marcepinc.com info@marcepinc.com
  5. 5. Please register the following delegate/s for (For Additional delegates please photocopy this form) Organisation Details & Authorization: I / We Hereby Confirm To The Above And Authorize Our Participants To The Programme. Please Send The Invoice To: Company Name: Nominating Authority: Designation: Email: Company Postal Address: Tel No.: * This Booking is Invalid Without Signature Signature Participation Fees Include: Workshop kit Documentation, Refreshment, Luncheon, Certificate Of Participation NON- RESIDENTIAL PROGRAME Cell No.: Marcep Inc. Terms and Conditions Payment terms - Upon completion and return of the registration form, full payment is required not later than 5 business days from the date of invoice. Payment must be received prior to the event date. Marcep Inc. reserves the right to refuse admission to the event if payment has not been received. Cancellation, postponement and substitution policy - You may substitute delegates at any time by providing reasonable advance notice to Marcep Inc. In the event that Marcep Inc. postpones an event for any reason and the delegate is unable to attend on the revised date, you will receive full credit of the contract fee paid. On mutual agreement, you may use this credit for another Marcep Inc. event which must occur within one year from the date of postponement. Except as specified above, no credits will be issued for cancellations. There are no refunds given under any circumstances. Marcep Inc. is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/ postponement of an event. Marcep Inc. will not take any liability whatsoever if the event is cancelled, rescheduled or postponed due to act of God, natural calamities or any other emergencies. Please note that while course speakers and topics were confirmed at the time of marketing, for circumstances beyond our control, the organization reserves the right to substitute, alter or cancel the speakers and/or topics Marcep Inc. reserves the right to alter or modify the speakers and/or topics if necessary without any liability to you what so ever. Updates on any substitutions or alterations will be provided as soon as possible. Discounts All 'Early Bird' Discounts require payment at time of registration and before the cut-off date in order to receive any discount. Offered discounts by Marcep Inc. (including team discounts) must also require payment at the time of registration. All discount offers will stand cancelled if payment is not received at the time of registration. For group nomination reply on:queries info@marcepinc.com Payment Terms: Payment Is Required Within 5 Working Days From the Date Of Invoice. Account Transfer/Cheque/DD Should Be In Favour Of “Marcep Inc.” Payable At Par In Mumbai. Investment fees 01 Delegate - INR: 24,500/- (Base Price) Additional service tax of 15% is applicable Sales Hotline No.: or email: afsana@marcepinc.com 07506478464 Marcep Inc. Campz Landmark Bldg., 103, 1st floor, Next to Tata Motors Showroom, S.V. Road, Jogeshwari- West, Mumbai- 400102 Tel: 022- 30210100 Fax: 022- 30210103 info@marcepinc.com PARTICIPATION DETAILS Name: Designation: Email: Location: www.marcepinc.com 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

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