Raghunandan H Venkataram

Current Position:

Associate Professor and Industry Institute Interaction Chief Coordinator, JSS University, JSS College of Pharmacy, SS Nagar Mysore

Education & other Details

Master of Pharmacy (Dissertation: Immunochemistry) - BITS Pilani Rajasthan India. Pass out in 1995.
Bachelor of Pharmacy - National College of Pharmacy Shimoga Mysore University – Gold Medalist – 1993 Pass out.

Currently pursuing PhD program (off campus) in “Formulation and clinical studies in the therapeutic areas of Antidepressant, Anti obsess, Gall stone treatment drugs” Expected to complete in August 2013

Registered Pharmacist as per Indian Pharmacy Council.

Active member of ISPE and participated in many seminars and discussions.

Member of American Society for Quality (ASQ)

Carrier Achievements till date: Pharmacist with extensive background (16 Years+) in the fields of Regulatory affairs, Quality control and Quality assurance, Manufacturing, in pharmaceutical, Biopharmaceuticals, Parenteral dosage forms like Small volume and Large Volume parenterals, dry powder, OTC and Oral Care formulations & Contract Manufacturing Management, Quality & ISO Audits of both manufacturing testing (GLP) and supplies including Medical devices and Clinical Trial Centers. Overseas work experience in manufacturing of pharmaceutical formulations and contract manufacturing quality management. Implemented QMS at 6 contract manufacturing sites at SEA (South East Asia). Well versed with the international quality audit requirements (USFDA, EUGMP, TGA, MHRA, HSA) from GLP and cGMP (GxP). Lead the team in implementation of ERP, BPCS and SAP. Having good knowledge on 21CFR part 11 ERES (electronic signatures and records) & expert in computer system.

Pharmaceutical /Health Care Industry Experience (16 Years +)

International Accreditations for various facilities:

• USFDA approval for sterile fill finish SVP and LVP and APIs
• ANVISA approval for biologics like Insulin, GCSF and SK
• QP approval from EU
• MOH Iran approval for Solid orals
• MOH Jordan for Biological products ( r DNA) and Injectables
• Yemen MOH approval for solid Orals of Immunosuppressant.
• ISO 9001
• KSFDA, Indonesian MOH for SVP lines.
• AFSSAPS
• Bfarm Germany

Other Expertise:

• Developed and Conducted training on all the quality policies ( Management Review, CAPA, Audits, Change Controls, Artwork Management, GLP GDP,cGMP Sterile Operations, Fermentations)
• Tablet Operations and setting up of Blue Chip Process
• Lyophilisation Process and validations
• Area Classification for Sterile areas and training of the Staff
• Risk Management as per ICH.
• OOS as per federal standard requirement.
• Product Knowledge in rDNA like Insulins,GCSF, SK
• Audited clinical supplies, CROs, depots for clinical supplies
• BA/BE knowledge base, Preclinical and Clinical GMP systems, blinding requirements
• Viral Validations
• Fermentation based product manufacture.
• Preparatory Chromatography system (Gel, Gradient etc).

Trainings undergone:

• LE program by Senn Delaney UK
• Sterile Fill Finish process ( Sterile area Behaviors and Processes)
• Sterile Area classification and maintenance for Injections ( EU, ISO, USFDA classification of areas)
• QbD and MABs manufacture and Validations by GE life sciences
• Negotiation Skills, Conflict Management
• Risk Management as per ICH.
• OOS as per federal standard requirement.
• Risk taking ability
• Certified GMP/GLP Auditor
• Leadership Management by Think Talent
• Certified Auditor Course
• Certified ISO Auditor Course
• Green Belt Certification ( SIX SIGMA)
• Operational Excellence Program conducted by GSK SRILANKA

Publications:

Achievements:

• Instrumental in placing more than 150 Pharmacy Post Graduates in various Pharmaceutical Companies Pan India during 2011-12, 2012-13.
• Invited Speaker on Safe Medicine to India – NGO at Indian Habitat Center New Delhi on 15th of Feb 2013
• Supported the proposal of CDSA as a QA Lead and the institution JSS University and instrumental in getting the approval as a Center of excellence for Clinical trials for CDSA – 2.0 Crores INR grants.
• Part of Innovation Group – Visited Helsinki from 2nd of September2012 to 8th of September 2012 – Indo Finnish Collaboration workshop on Incubation systems on e-Health- This was sponsored by DST.
• Carried out Carrier Guidance Program at JSS Private School Dubai on 11th March 2012
• Delivered a Seminar on registration process at Canada on 17th of Feb. 2012
• Nominated as General Secretary for South India SPDS ( Scientific Pharmaceutical Dissolution Sciences)
• Delivered a talk on Future Perspective of Pharmaceuticals in IPA student congress held at JSSCP Ooty on 26th and 27th of April 2013.
• Delivered a talk at BG Nagar College during Pharmacy week celebrations in 10th Feb 2012 on an Overview of International Regulatory in pharmaceutical Sciences

Personal Details

Date of Birth: 20th May 1972
Nationality: Indian
Worked abroad for 24 months and traveled overseas extensively on Pharma business for Quality audits of manufacturing, Clinical Trials supplies depot, QMS at Contract manufacturing and logistics in more than 30 countries