RAPS Approved Seminar on Complying with GMP and cGMP Requirements: Streamlining Quality Assurance and FDA Compliance

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RAPS Approved Seminar on Complying with GMP and cGMP Requirements: Streamlining Quality Assurance and FDA Compliance Powered By Docstoc
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                                                                          India Seminar 2012 at Mumbai

     RAPS Approved Seminar on
     Complying with GMP and cGMP Requirements: Streamlining
     Quality Assurance and FDA Compliance RAPS Approved. Earn 12 RAC Points
     Course "Complying with GMP and cGMP Requirements: Streamlining Quality Assurance and FDA
     Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a
     participant's RAC recertification upon full completion.

Overview
Dr. Kuwahara’s presentation will benefit all kinds of pharma                        Steven S Kuwahara
companies, right from small molecule drug companies to                              Founder & Principal, GXP
biologics companies and API and generics manufacturers                              Biotechnology, LLC
                                                                                    Steven S. Kuwahara, Ph.D. is the
It will be very useful for Managers, Directors, Regulatory                          founder and Principal of GXP
Associates and Analysts. The seminar will offer important                           BioTechnology LLC, a consulting firm
learning to Quality and Regulatory and Research and                                 that works in the areas covered by the
Development groups Heads.
                                                                GLP and GMP of drugs, biologics, and nutraceuticals.
                                                                Steve has over 30 years of experience in supervising quality
               Download Brochure                                control laboratories, including an animal testing facility, and
                                                                in performing GLP and GMP audits of internal and external
                                                                testing laboratories .
     Date and Venue                                                                                                      more...

     June 18th, 19th and 20th, 2012

     Venue: WILL BE ANNOUNCED SOON                                     Download Registration Form

                                                                                 For Sponsorship
Agenda                                                                        Conference timings: 9:00 am - 6:00 pm

    Day 1 - 18th June 2012                   Day 2 - 19th June 2012                    Day 3 - 20th June 2012
    Introduction to U.S. Drug Regulation: (90 Violations and Responses: (90            An Overview of ICH Q8, Q9, and Q10:
    minutes)                                  minutes)                                 (90 minutes)
    l  The U.S. Food, Drug, and Cosmetic     l   Inspections                              ICH Q8 (R2), Pharmaceutical
                                                                                        l
    Act                                      l   Observations and 483's                 Development
        l Key amendments to the Food,        l   Warning Letters
                                                                                           l Its Impact of Research
        Drug, and Cosmetic Act               l   Beyond the Warning Letters
                                                                                           l CQA and Design Space
        l Definitions of Drugs, Biologics,   l   Responding to the U.S. FDA
                                                                                        l ICH Q9 Quality Risk Management
        and Devices
                                                                                           l Risk Management Process
    l The U.S. Good Laboratory Practices     Filings and Submissions - DMF and             l Risk Management Process
    (GLP)                                    Clinical Trials: (90 minutes)              l ICH Q10 Pharmaceutical Quality
    l The U.S. Good Manufacturing
                                             l   Drug Master Files (DMF)                System
    Practices (GMP)
                                             l   Clinical Trial (Research) Permits         l Relationship to GMP, ISO and
                                                 l Early Phase (Pre-clinical)              ICH Q7
    Laws and Regulations in the U.S: (90         l Phase 1                                 l Management of the System
    minutes)                                          l Phase 1a

        FDCA to the regulations                       l Phase 1b
    l
                                                 l Phase 2
         l Pharmacopeias                                                               Risk Analysis and Corrective and
                                                      l Phase 2a
         l Points-to-Consider                                                          Preventive Actions (CAPA): (90
                                                      l Phase 2b
         l Guidance Documents and their                                                minutes)
         effect on the GMP                       l Phase 3
                                                      l Pivotal Trials                  l   Root Cause Analysis
         l The International Conference on
                                                 l Special Clinical Studies                  l Brain Storming, Brain Writing
         Harmonization (ICH)
                                             l   Applications under the Animal Rule          l Fish Bone Diagrams and
         l World Guidance and World GMP                                                                                             
                                                                                             related techniques
                                             Filings and Submissions - NDA and               l Risk assessment and
                                             BLA: (90 minutes)                               Scoring
    The U.S. Drug GMP- Part 1:(90 minutes)                                                  Fault Tree Analysis (FTA)
                                             l  The New Drug Application (NDA)          l

                                                 l The Abbreviated New Drug             l   Applications to CAPA
    l Key definitionss
    l Basic requirements of the GMP -
                                                 Application (ANDA)
                                                 l Special Drug Applications           Biosimilars in the U.S., An Overview:
    Part 1
                                             l The Biologics License Application       (90 minutes)
       l Organization and Personnel
       l Buildings and Facilities
                                             (BLA)                                          The U.S. Guidance Documents
                                                                                        l
                                             l The ICH Common Technical
       l Equipment                                                                           l Proof of Similarity
       l Control of Components
                                             Document (CTD)
                                                                                             l Importance of Animal Studies


    The U.S. Drug GMP - Part 2: (90          Inspections and Audits:
                                                                                       Process Validation:
    minutes)                                 (90 minutes)
                                                                                       (90 minutes)
                                             l The Quality System Inspection
    l Basic requirements of the GMP -          Inspections by Regulatory Bodies         l  Combining the other validations
                                             l
    Part 2                                   l Preparation for Inspections and          l  The FDA Guidance Document on
       l Production and Process Controls     Audits                                     Process Validation
       l Packaging and Labeling Controls                                                l Maintaining the process in a
                                             l Managing an inspection or audit
       l Holding and Distribution                                                       validated state
                                             l Responding and follow-up to 483s
       l Laboratory Controls
                                                l Need for CAPA
       l Records and Reports
       l Returned Goods and Salvaging




 
     
                                                    Pricing List
        Contact Information:
        Event-coordinator
                                                    Register By                             Price INR            Savings
        Phone number: +91 80-3221-3341 /
        +91 80-3247-3696 / +91 80-3221-             Between March 26th to May 26th          16,000               2,000
        3329.
        Fax number: +91 80-2642-1483
                                                    Between May 27th to June 17th           18,000               0
        Email:
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        GlobalCompliancePanel                                                                                                         
                                                    We will be able to accommodate limited number of attendees so if you and
        C/O NetZealous Services India Pvt. Ltd.
                                                    your colleagues would like to attend this training seminar, call us today at +91
        4th Floor, A, Block, Brigade Software
        Park, Banashankari 2nd stage,               80-3221-3341 / +91 80-3247-3696 / +91 80-3221-3329 to reserve your seat.
        Bangalore-560070. INDIA
                                                    Download the Registration Form

                                                    Best regards,
                                                    Team
                                                    GlobalCompliancePanel


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DOCUMENT INFO
Description: Dr. Kuwahara’s presentation will benefit all kinds of pharma companies, right from small molecule drug companies to biologics companies and API and generics manufacturers It will be very useful for Managers, Directors, Regulatory Associates and Analysts. The seminar will offer important learning to Quality and Regulatory and Research and Development groups Heads.