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
Training Cost: INR 11,000 + 18% GST extra =INR 12,980 (Including GST) **Scroll Down For Key Topics, Trainer’s Profile, Programme Deliverables, Target Audience*
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.
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.
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.
How to Manage Change and Configuration in Effective way
Calibration, Qualification and Validation
CFR part11 compliance
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