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With regulatory agencies’ broadening scope of compliance requirements along with increased frequency of inspections and upward trend in warning letters,  business expediency requires management to train their personnel in ever-changing regulations. Poor compliance management, internal controls to secure data and quality systems are some of the biggest concerns.

Companies will need to realign their quality and compliance structure to conform to the constantly evolving regulatory guidelines. Any violation of regulatory methods or non-compliance of standards could increase the exposure to a company’s risk of receiving warning letters thereby reducing the company’s worth in the eyes of patients as well as investors. Consequently, it is critical that companies start making regulatory compliance a part of their corporate strategy. Such a strategy should include making compliance a proactive activity wherein stringent internal controls are established to demonstrate their commitment towards quality and compliance.

Markets and Markets, a worldwide leader in conducting currently trending seminars for the pharmaceutical industry has teamed up with industry experts for this interactive seminar titled “Proactive & Sustainable Compliance Workshop”  Set for 7th & 8th December in Mumbai, it is designed by a panel of international experts to shed light on recent compliance challenges confronting the biopharmaceutical industry worldwide with a special focus on the Indian industry.  This highly interactive workshop series is being offered to familiarize biopharmaceutical industry professionals withend to end compliance solutions. It will provide attendees a better understanding of compliance related elements across the biopharmaceutical supply chain.

Attending this workshop will provide you the required skills to keep your company compliance ready. It is designed for novices and advanced users alike and benefits those in senior management and manufacturing personnel from pharma, bio-pharma and life sciences industry in general.

conference Registration Form

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CategoryCost
Standard Registration Fees (2-Day Program)35,000+ 18% GST= INR 41,300
Standard Registration Fees (1-Day Program)20,000+18% GST = INR 23,600
Early Early Bird Discount (2-Day Programme) - 31st July 201725,000+18% GST= INR 29,500
Early Early Bird Discount (1-Day Programme) - 31st July 201712,000+18% GST = INR 14,160

Agenda

Workshop Series


Day 1 - Process and Plant Systems


Module I
Materials Management Compliance

Module II
Compliance for Engineered Systems

Module III
Quality Management Systems - developing and sustaining a quality culture

Module IV
Management of Production and Process System

Module V
Developing Effective SOPs

Module VI 
Recent Trends in FDA 483 Warning Letters

Day 2 - Computerized systems


Module I 
 Data Integrity and computerized systems basics 

Module II 
Data Integrity and its insidious nature

Module III 
Data Integrity in the Laboratory

Module IV 
Leveraging Automation and Advanced Technologies to Overcome Regulatory Compliance

Module V 
 Data Integrity Issues for Clinical Trials 

Module VI 
How is Data Integrity audited

 


Workshop Highlights


  • Meeting appropriate quality attributes of materials
  • Identifying poor GMP and analytical practices
  • Quality requirements for batch release
  • Incorporating advanced quality risk management
  • Adopting processes for regulatory changes
  • Overcoming challenges in product variability and product reviews for better quality
  • Undertaking internal audits
  • Ascertaining criticality and qualified equipments/instruments
  • How to efficiently handle OOS and OOT handling
  • What methods are to be adopted for new equipments and products?
  • Introduction of New products & Process Validation system 
  • Understanding the essence and maintaining SOPs
  • Reviewing import alerts and warning letters
  • Why is 21 CFR Part 11 not data integrity
  • Data trends analysis – what are the missing steps?
  • What is data integrity and why is it important?


USP’s of Proactive & Sustainable Compliance Workshop Series


  • First ever workshop series on end to end compliance needs and solutions across all operations
  • Workshop conducted by expert panel including internationally recognized compliance expert with extensive hands-on experience in working with FDA and FDA panels.
  • Bring your individual problems for one-on-one and workshop-wide interactive discussion so that you can directly apply the learning’s to your daily work upon your return
  • Numerous real-world case studies faced by companies worldwide.

To download the workshop series agenda or know more information about each workshop, kindly email us on events@marketsandmarkets.com

Who Should Attend ?

Job titles


  • VPs
  • Chiefs
  • Heads
  • Directors
  • Managers
  • Officers
  • Leads
  • Executives
  • Associates
  • Utility Engineers??
 

Departments


  • Compliance
  • Quality
  • Quality Assurance
  • Quality Control
  • Quality management
  • Quality IT
  • Manufacturing
  • Validation
  • Regulatory
  • Analytics
  • Corporate Quality 

SPEAKERS

  • Yateen Shah

    General Manager- Quality Operations (Business Quality) Johnson & Johnson Pvt Ltd., Mumbai, Maharashtra, India
  • Sunil Chaturvedi

    QA Compliance & Auditing Novartis Global Pharma, Mumbai, Maharashtra, India
  • Nitin Kohojkar

    Deputy General Manager - Senior Global Quality Assurance Auditor Sandoz, Mumbai, Maharashtra, India
  • Arvind K Mishra

    Chief Strategy Officer Nuwill Research & Innovations Pvt. Ltd, Bangalore, Maharashtra, India
  • Chinmoy Roy

    Data Integrity and CSV SME Consultant, San Fransisco, USA
  • Saravanan Muthiah

    Head - RA (Formulation) Concord Biotech Limited, Formulation Division, Gujarat, India
  • Dr Subhash Pande

    Senior Vice President- Corporate Quality Assurance Zydus Cadila, India
  • Suryamohan Surampudi

    Head - Plant IT GxP Assurance & Administration Dr. Reddy's Laboratories, Hyderabad, India
  • Linga Rao

    President – Technical Affairs , Natco Pharma , Hyderabad, Telangana
  • Deepak Haldankar

    Exe.V.P. - Quality and Reg. Affairs , Srikrishna Pharmaceutical , Hyderabad, Telangana
    

SPONSORS

MarketsandMarkets provides a variety of direct and indirect marketing and networking opportunities for sponsors and exhibitors. 

Exhibiting


All refreshment breaks and lunches take place in the main exhibition ensuring that exhibitors enjoy maximum time to meet and network with senior level attendees. 

Speaking and Workshop Opportunities

 

  • 15 minute small company showcase presentations.
  • 30 minute presentations on the main conference programme.
  • 25 minute satellite symposiums.
  • 60 minute presentation/workshop on the main conference programme.

Please enquire for pre and post events workshop options. 

Pre-arranged One-on-Meetings


Prearranged one-on-one meetings ensure that you have personal time with your choice of delegates. Twenty-minute meetings take place during refreshment breaks. Full delegate profiles are provided prior to the conference to ensure that onsite, you meet with relevant delegates who are truly interested in your products and services. Meetings can take place on your exhibition or in your own private meeting area. 

Pre-event Support
MnM Conferences provide full service pre-event marketing and branding support. Opportunities available include: 

 

  • Your logo and company description on the event website.
  • Your logo on all marketing materials as a sponsor.
  • Pre-event email shots to attending delegates to increase your onsite exposure.
  • Articles about your products and services in our monthly event newsletter.

For sponsorship opportunities please contact us at events@marketsandmarkets.com

Media partners

SUPPORTING ASSOCIATIONS

To support Proactive & Sustainable Compliance Workshop Series, please contact Amit at amit.shelke@marketsandmarkets.com