Clinical Data Management Webinar

PROGRAMME DETAILS

Training Dates:  25 FEB 2021 to 01 MAR 2021

Batch Timings: 08:00 PM to 10.00 PM IST

                09:30 AM to 11:30 AM EST (US)

Programme Duration:  10 Hours 

PROGRAMME FEES:

Training Cost: INR 11,000 + 18% GST extra =INR 12,980 (Including GST)

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Hours
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TRAINER'S PROFILE :
MR. KALPESHKUMAR R. VAGHELA

  • Mr. Kalpeshkumar R. Vaghela is the CEO of Infra Control Systems and Founder partner of KVS Technologies.
  • He has 34 years’ experience as Automation and Software Validation Specialist, Expert Trainer on CSV- Data Integrity- GAMP5- 21 CFR part 11 Compliance- ICH Q9 Risk assessment- Proactive CSV Approach-Annex11- GDPR- Remediation.
  • Since last two decades Mr. Kalpeshkumar Vaghela has been helping Indian and International Pharma – Process Companies achieve compliance by training and motivating professionals for QbD, and Right First Time Approach.
  • He has supported client for many USFDA, MHRA, ANVISA, MCC, TGA Audits as a CSV- GxP consultant.
  • He also helps in GAP Assessment, Data Integrity Audit and Remediation program.

PROGRAMME DELIVERABLES

  • A comprehensive study material for all the modules in soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

TARGET AUDIENCE

  • Experienced professionals in Quality Assurance / Pharmacovigilance / Clinical Trail Operations / Medical writing / Clinical data Management / Clinical SAS Programmers / Regulatory Affairs
  • IT, QA, & Business Managers and Professionals who need to: 
  • Manage or participate on computer system projects requiring validation.
  • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
  • Understand the process of computer system validation.
  • Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meet the latest regulatory expectations.
  • Understand the FDA and international regulatory landscape around CSV.

Topics

  • GAMP 5
  • How to Manage Change and Configuration in Effective way
  • Calibration, Qualification and Validation
  • CFR part11 compliance
  • Annex 11
  • ALCOA+
  • GDP- Good Documentation Practices and ERES Practices.
  • Mastering Computer   Systems   Validation
  • 483 –warning letter Response & Remediation
  • Risk Assessment and Management
  • Brief Details on Cloud Validation   –   IaaS, SaaS, PaaS,   Types   of   Cloud, Importance of SLA
  • Periodic Review   Protocol   and   Report (Reduce   your revalidation work scientifically)
  • Good Check list to control Data Integrity
  • Eight habits of highly compliant Organizations
  • cGMP as per 21 CFR 211 Key points
  • GxP Work Flow
  • Data Life Cycle
  • Software Development Life Cycle
  • Vendor and Equipment Qualifications.
  • How to host Data Integrity Audit.
  • Three Process Flow Can help you control CSV in best possible way.
  • Black Box- White Box Validation
  • Legacy – Hybrid Systems
  • Open – Close Systems
  • Open Close – Culture
  • Software – Hardware Category as per GAMP5
  • Risk based work based on Novelty- Complexity and Critical Thinking
  • Static – Dynamic Data
  • Raw- Meta Data
  • Active – Passive Data
  • Analyses of One 483 – Warning letter
  • Good Remediation
  • Multiple Case studies
  • Role of FDA to 482-482-484-EUA
  • Type of inspection by FDA
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