Computer System Validation


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DATE

27-28 September, 2018

LOCATION

Mumbai

TIME

08:30 AM TO 05:30 PM

Our Workshop Leaders

  • David Thompson

    Managing Director & Principal Consultant - Clarity Compliance Solutions Ltd.

    Dave is a Computer Systems Validation and Compliance expert. He has worked in the IT / Computer Systems arena for almost 30 years, the last 16 years he has provided consultancy, auditing and training to the pharmaceutical/biotech and healthcare industry across the UK, Europe, Asia and the U.S.A. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG. In his current role he is the Owner and Principal Consultant of Clarity Compliance Solutions Ltd.


Who should Attend

  • Novices
  • Advanced users
  • Senior management
  • Who use computer systems for laboratories, clinical trials, manufacturing, quality, validation
  • IT system vendors

Key Topics include

  • Pharmaceutical Quality Systems Elements (PQSE)
  • Data Integrity elements
  • Corrective and Preventive Action (CAPA)
  • Computer Systems Validation (CSV)
  • Implementation of Six Sigma concepts
  • Software Quality Assurance (SQA)

Workshop Include

  • Presentations
  • Panel discussion
  • Group discussion
  • One-to-one discussion
  • Chalk and talk
  • Case Studies

Some training highlights...

  • International developments in pharmaceutical manufacturing and their likely impact on GCC
  • The increased role of and techniques used by management to ensure compliance
  • What are the elements of a PQSE with examples of each (ICH Q10)
  • What is CAPA and what are compliance requirements for CAPA
  • What are the attributes of quality SOPs
  • Structure and example of a Validation plan
  • Data Integrity, CFR 21 Part 11 and Annex 11 and their differences
  • Validation considerations for Commercial off the shelf (COTS) software from software vendors
  • How to write good requirements documents and why are they always audited
  • Mock internal audit for PQSE, CSV and CAPA performed by trainees

Speakers of 2018

user

Pranav Gadre
Piramal Enterprise Ltd
Head Pharma IT Compliance

user

Aniruddha Mehta
Alembic Pharmaceuticals
Head QA -IT

user

Ananda Rao. C
Navitas Life Sciences
Associate VP- Head QA and CSV

user

Jitendra Mishra
Wanbury Ltd
VP. CIO


user

Pravin Bhatkulkar
Cipla Ltd
Quality IT

user

Dr Rashmi Hegde
Cipla Ltd
Vice president Medical affairs

user

Dr. Anil Fokmare
Alembic Pharmaceuticals Ltd.
Head- Quality (Formulation-Unit 3)

user

Vivekram. A
Senior Validation Specialist - Ziffo
RnD Solutions


user

Abhinaya. R Head
Validation Services
Ziffo , RnD Solutions

If you’re using computer systems for laboratories / clinical trials / manufacturing / quality / validation, you don’t want to miss this opportunity to meet with strategic leader in IT / CSV / QA.

Download The Prospectus To See How You Can Get Involved

Sponsorship Opportunities

Want to be in front of a large and engaged group of industry leaders who are serious about building relationships to build their businesses?

This event will provide sponsors with the unique opportunity to showcase their services and technologies to the most active stakeholders in the industry today! Do you have a solution that can help their challenges?

Request a Sponsorship Prospectus

MEET FOLKS THAT MATTER

Attendees have acquisition power and are actively looking for industry partners

GET NOTICED

From speaking, leading a round table, hosting receptions, there’s so many ways to highlight your company.

SHOWCASE YOUR SOLUTIONS

We hand pick the top vendors that can assist with our attendees challenges to showcase their solutions through and exhibit booth.

Contact Us

For Registraion

Rachna Tiwari

Conference Manager
rachna.tiwari@biotrains.com
+91 8433632006