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Workshop Overview
Global Regulatory Agencies & cGMP compliance, always expect that complaints, failures and deviations are handled in a systematic & timely manner. In this process, the impact on the “Product Quality” has to be assessed, and measures have to be taken to remedy such deficiencies and avoid them in the future.
This conference will familiarise you with the regulatory requirements and introduce you to the essentials of failure handling. The emphasis is on the independent handling of Complaints, failures and deviations in your everyday work. In the case of studies, practical strategies from practice are presented to you; in breakout sessions, you work out solutions to failures and deviations typically occurring under different. scenarios.
Course Director
Ranjit Barshikar
CEO – QbD International
(Quality by Design / CGMP Consulting – BioPharma / Pharma)
United Nations Adviser- MPP Geneva
Editorial Board Member- Journal of Generic Medicines UK.
Ranjit Barshikar
CEO – QbD International
In a career span of 51 years, he has rich & varied experience in the Pharma Industry, especially in Quality Management, R&D, Mfg., Regulatory, US FDA / EU / WHO etc., compliances.
Currently: CEO- QbD International (Quality by Design / CGMP Consulting — Bio-Pharma / Pharma). United Nations- Geneva Adviser
Member of Editorial Board of Journal of Generic Medicines – England.
Expert on Quality by Design / Data Integrity / CAPA / Quality Culture & various other CGMP subjects.
Expert Auditor of “Formulations” & “API” facilities / CRO etc.
Major Awards
- “Quality Champion – Gold” Topmost Quality Award by Govt. of India – Quality Council of India.
- “Lifetime Achievement” Award by International UNICEF Council- USA.
- “100 Most Impactful Healthcare Leaders -Global” Award by World Health Congress / ET.
- “Pharma Ratna” Award by largest NGO RabDiMeher. (in addition to 34 other awards)
Amit Guru
Regional Director, Solution Enginnering, APAC,
Sparta Systems, A Honeywell Company
Amit Guru
Regional Director, Solution Enginnering, APAC,
Amit leverages his wealth of subject matter expertise in quality systems, enterprise software deployments, computer software validation 4.0, regulatory compliance, audit, IoT, Pharma 4.0 & compliance, risk management, validation & qualification and the life science industries to support ongoing sales enablement and services efforts in India and the Asia Pacific region.
Amit has worked in various organizations like Ranbaxy, Sunpharma, Cipla, Strides, Merck etc and having over two decades of experience Manufacturing, Research, QA, QC of Pharmaceutical/ Medical Device Industry, IT Project Management, Leadership, Strategic Business Management, GxP Software Implementation etc. He believes in transforming the systems at the organization, moving to entire paper less, connected, integrated system where data can be transformed into wisdom.
Guest Speakers
Dr. Sanjay Jain
President, Amneal India
Dr. Sanjay Jain
Dr. Sanjay Kumar Jain has oversight for all aspects of Amneal India operations, including managing the overall productivity and quality deliverables and leading Amneal as “President – India Operations”. He holds a degree in Pharmacy, a post graduate degree in Quality Management and Ph.D. in Operation management. He has extensive experience managing Operations, Validation and Quality, as well as Regulatory audits originating from the USFDA, MHRA, EU, TGA, Anvisa, MCC and Health Canada. He has developed quality systems, implemented various process improvement projects, and successfully faced regulatory audits of various regulatory agencies multiple times. He is a member of the ISPE and PDA. He is on PDA’s Board of Studies. He is an accomplished speaker at various international conferences. Dr. Jain has published chapter in book and 10 papers in various national and international journals.
Dr. B M Rao
Head – QA for Emerging Markets,
Dr. Reddy’s Laboratories
Dr. B M Rao
Dr. B M Rao possess a Ph.D. degree in Chemistry and has about 31 years of work experience in pharmaceutical Analytical R&D, Quality Control & Assurance functions in reputed organizations includes Janssen (pharmaceutical companies of Johnson & Johnson), Novartis, Zydus Cadila, Nicholas Piramal, and Dr. Reddy’s. He has extensive hands-on experience on analytical instruments/techniques related to chromatography, spectroscopy and thermal analysis etc.. He has exposure to various regulatory audits includes USFDA, EMEA, TGA, Health Canada etc. and worked with reputed International consultants in QC remediation. He has about 80 scientific publications in reputed peer reviewed national/ international journals and successfully guided eight Ph.D. students.
During his professional career he has been recognized for his contributions at work and won awards including Chairman’s Excellence Award from Dr. Reddy’s Laboratories (Feb, 2018 & Jan, 2003), “Standards of Leadership” from J&J at Janssen, Mumbai site (year 2010) and Best New Leader Award at SAI Life Sciences Limited (year 2013). He has extensively travelled to USA, Mexico, Europe, Germany, Belgium, Singapore, Brazil, and Malaysia and interacted with several big and emerging biotech pharmaceutical analytical & quality experts.
Since September 2015, Dr. BM Rao is working as Head of Quality for Emerging Markets, Analytical Science & Technology (ASAT) & Corporate Quality control at Dr. Reddy’s Laboratories and providing technical leadership to the Analytical method validations/transfers and Quality Control labs of APIs and Formulations.
Dr. Umesh Kale
Chief of Quality Services, Strides
Dr. Umesh Kale
Umesh Kale has done his M. Pharm from SGSITS, Indore and has over 26 years of industrial experience.
During these 26 years, he has worked in various capacities including that of Sterile Injectables (Production), Technology Transfer, Validation & Qualification, Design Quality, Regulatory Affairs, Site Quality Head and Corporate Quality Head for both Drug Substances as well as Drug Products.
He is currently working with Strides Pharma Science Ltd., as Chief of Quality Services. Prior to Strides he was working with Ranbaxy, Dr. Reddy’s, Lupin, FDC and Nicholas Piramal.
While Qualification and Validation are Umesh’s forte, he brings in lot of expertise when it comes to Risk Management, QMS, Digitization, Quality Metrics, Quality Behavior and overall culture of Quality. He has conceptualized and led several projects in these areas and have hands on experience on these topics.
Umesh believes that Quality professionals in Pharma have a great opportunity in creating vision for the industry and lead them too to manufacture and supply high quality products through reliable, trustworthy, transparent and consistent processes and serve humanity.
Dr Rajiv Desai
Executive Vice President, Corporate Quality, Lupin Ltd
Dr Rajiv Desai
Dr Rajiv Desai, Executive Vice President, Corporate Quality, Lupin Ltd. responsible for Quality Management of the API and Formulations sites.
Lupin is an innovation-led transnational pharmaceutical company. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector. The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions.
Lupin Ltd is the eighth largest Generic Pharmaceutical company in the world with manufacturing facilities located in India, USA, Brazil and Mexico.
Career highlights:
- Over 33 years of experience in the Pharmaceutical Industry
- Experience in the Pharmaceutical Industry spreads across basic research, Technology transfers, Quality Management and Regulatory affairs
- Previous assignments, as head of Corporate Quality Management at Dr Reddys, Mylan, Piramal and Alembic Pharmaceuticals
- Started career with Ciba Geigy (now Novartis) in R&D and Technology transfers with assignments in India and Switzerland
- Member of the US Pharmacopeia Expert committee between 2010 and 2015
- Nominated as a Subject matter Expert Member in the Indian Pharmacopoeia
- Invited to deliver lectures at various international and national scientific forums
- Actively working on several board of studies of reputed universities in India for short term teaching assignments and syllabus revision programs for post graduate courses
- At UDCT ( now ICT, Mumbai), appointed as visiting faculty, under the Daiichi Karkaria memorial endowment faculty program for the year 2013 – 2014
Qualification:
Ph.D from UDCT ( now ICT), Mumbai in Pharmaceutical Chemistry and a post graduate degree in Business Management from NMIMS, Mumbai.
- Key Benefits of Attending
- Who should Attend
Systematically handle deviations and failures in the manufacture of API / Pharma products to evaluate them in a cGMP-compliant way.
Step by Step implementation of CAPA process to ensure effectiveness as per US FDA / ICH guidelines.
Case studies to demonstrate the evaluation and handling of real-life deviations and failures.
In breakout sessions, you discuss and work out autonomous solution strategies for losses that occurred.
You can discuss failures and deviations from your daily practice with speakers and colleagues.
Quality Culture is necessary at all levels for excellence in CAPA handling as the way forward.
ICH Q9 Quality Risk Management & ICH Q10 Pharmaceutical Quality System requirements.
Importance of systematic documentation of CAPA process.
Quality Assurance & Quality Control Department
Manufacturing Departments
Product / Process Development
Qualification / Validation – who are handling failures and deviations & Investigations CAPA.
R&D Teams
Regulatory Professionals
Key Highlights
Understanding the Regulatory Guidelines
• CDSCO – India • US FDA • EU requirements
Pharmaceutical Quality Systems
• ICH Q10 Pharmaceutical Quality System • ICH Q9 Quality Risk Management • USFDA Quality Systems – Maturity Model
• What is Industry 4.0? • What is Pharma 4.0? • Benefits in CAPA investigations
•Benefits • CAPA investigation • Complaints Handling • Artificial Intelligence
Current scenario in the Pharma Industry
• Compliance Failures • Recent USFDA / MHRA / EU observations • Challenges
• Identifying Root Causes. • Root Cause • Root Cause Analysis Tools: Brainstorming, • Ishikawa, Pareto Chart, Process Mapping, 5 Whys.
• Stakeholders support • Procedures
• CAPA System • CAPA Steps • Creating Action plan
• Responsibilities • Implementation Steps • Effectiveness Check • Effectiveness Verification
• Non – sterile products • Sterile products • Examples
• 483’s , Warning Letters • US FDA / EU Observations
Several Examples , Case studies
Media Partners
Pharma Utility, a magazine dedicated to news and services in the Indian pharmaceutical Industry.
IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013 .
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