COMPUTER SYSTEM VALIDATION WORKSHOP
PROGRAMME DETAILS
Workshop Dates: 15 Mar 2021 (Monday) to 19 Mar 2021 (Friday)
Workshop Timings: 07:30 PM to 9.30 PM IST
Workshop Daily Duration: 2.0 Hours
Mode of Workshop : Zoom Meetings
PROGRAMME FEES:
Rs 20,000 + GST(18%)
Total Fees amount = Rs 23,600
Per candidate
Early Bird Offer: Rs 17,000 + GST(18%)= Rs 20,060
***Early Bird Offer ends on 08-Mar-2021***
**PAID WORKSHOP**
*Scroll Down For Key Topics, Trainers Profile, Target Audience*
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TRAINER’S PROFILE
Dr.Balaji Kuzhandhaivelu is an Independent Consultant for Pharmaceutical, Biologics, Clinical and Medical Devices domain, associated with various domestic and international consulting firm located in USA, Canada, UK, Europe and China. He holds a master’s degree from the University of Madras in Industrial Microbiology and Doctorate in Nanotechnology from VIT University, India.
Professionally, he was Certified Quality Auditor and Certified GMP Professional from American Society for Quality.
In his tenure of 20 years of services, he served as quality control laboratory professional and Quality. Compliance manager in Orchid Healthcare, served as Lead for Audit and compliance in Strides Arcolab, as Corporate Global Quality Head for Xellia, Compliance Manager for Johnson & Johnson Asia Pacific and Country Director for EU Consulting firm operations.
For last 6 years, he was been associated with various international consulting firms and supported for GxP Audits worldwide, FDA Remediation Projects, Technical Trainings for clients located globally. He makes regular webinars/seminars around the world on QMS, Validation, Microbiology, Sterility Assurance and Computerized System Validation services.
He was also supported for technical GxP Third Party Audits, GxP Gap Assessment, Data Integrity and Governance Program Plan and USFDA/EU Remediation projects worldwide.
He has faced many regulatory inspections from PMDA, USFDA, UKMHRA, ANVISA, MCC, GCC, TGA, KFDA worldwide.
TARGET AUDIENCE
Industry Experts from Various domains included:
- Pharmacy (B.Pharma/M.Pharma/Pharm-D)
- Medicine (MBBS/BDS/BAMS/BHMS/BPT)
- B.Sc/M.Sc (Nursing/Biotech/Chem/Bio-chem/Micro-Biology)
- All professionals working with Pharmaceutical Companies, CROs, Academics and Hospitals
- All teaching professionals (In Life Sciences) who wish to enter Clinical Research industry
- Students in their final year of graduation for the above courses are also eligible to apply
- 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.
List of Topics included for Certified Workshop
- Review of Computer system validation requirements for all GXP related
system includes Standalone, Server based, Infrastructure reviews.
- Perform Gap assessment for all GXP related system as per 21 CFR Part
11 and EU Annex 11.
- Data collection and Gap assessment for all GXP related computerized
system for all GXP software.
- Assessment Report for all GXP related instruments and identification of
CAPA Plan.
- Execution of CSV Process: IQ, OQ and PQ for Laboratory software.
- Why to choose “Cispact trainings” for CSV to learn and many more…! Workshop Certificate will be Provided along with all the topics mentioned here.