Day 1 :
Keynote Forum
Michael D Spangler
Spangler Consulting LLC, USA
Keynote: A blueprint for outsourcing audits of approved GxP validations
Time : 09:05-09:45
Biography:
Bernice Brempong holds a Bachelor degree in Pharmacy from University of Ghana, Legon. She has extensive experience in hospital practice, community practice and pharmaceutical production. She has worked in several pharmaceutical industries including Ernest Chemist in 2013 and Entrance Pharmaceuticals in 2016/2017 where she gathered practical experience and later assumed the Chief Executive Officer position in Makhealth Pharmaceuticals Limited. Makhealth Pharmaceuticals is currently putting up a WHO-GMP compliant facility in collaboration with international partners for the production of solid and liquid oral dosage forms and sterile products including dropper products, parenteral and vaccines. Makhealth intends to collaborate internationally in contract manufacturing and also to act as the state-of-the-art manufacturing industry in Sub-Saharan Africa.
Abstract:
Good Manufacturing Practice (GMP) is part of the quality management system which ensures that products are consistently produced and controlled to meet quality standards appropriate for their intended use as required by the marketing authorization, clinical trials authorization or product specification. Current Good Manufacturing practice (cGMP) is aimed at managing and minimizing the risks inherent in pharmaceutical manufacturing to ensure that the quality, safety and efficacy of products are reproducible. Such risks are essentially human errors which occur during the handling and processing of materials and machines. While most pharmaceutical industries from the industrialized world work tirelessly to comply with cGMP requirements to produce in compliant facilities, industries in the developing countries have not been able to meet most of these requirements. Factors such as lack of skilled personnel with technical know-how, weak regulatory systems, lack of appropriate equipment, machinery and technology and high cost of manufacturing drugs thus modern equipment and
technology among others have been identified as some of the major factors within the sector bringing about the differences we see today in developing countries. In conclusion, GMP guidelines provide the requirements that a manufacturer must meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use in order to always prevent harm from occurring to the end user.
Keynote Forum
Eleonora Babayants
Galaxy Consulting, USA
Keynote: Quality management and quality audit according to GxP/GMP requirements
Time : 09:45-10:25
Biography:
Eleonora Babayants is a Galaxy Consulting Founder and President. She is a Documentation Management Professional and hands-on consulting with over 25 years
of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management
systems, information governance, and change management. Her past work includes development and implementation regulatory compliance processes and
procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search,
improving systems information architecture, creating and implementing users training programs. She has led electronic document management systems selection
and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring
of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements.
She wrote technical documents and created document templates. Her experience spans multiple industries including biomedical, pharmaceutical, and medical
devices companies.
Abstract:
GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices and
cosmetics. GMP regulations describe required quality management system for production and testing of products in
these regulated industries. The purpose of the GMP regulations and quality management system is to ensure that a product is
safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance,
quality control and quality improvement. Quality audit is the process of systematic inspection of quality management system
which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality
management system and is the major part of GxP/GMP regulations. In this keynote speech, I will describe the framework of
GxP/GMP regulations, quality management system, and quality audit.
Keynote Forum
Joel Finkle
Acuta LLC, USA
Keynote: A personal history of regulatory submissions technology
Time : 11:50-12:30
Biography:
Joel Finkle is a Director of Regulatory Innovation and IDMP Strategy for ACUTA. In this role he brings new technologies and regulatory data standards to ACUTA’s bio/pharmaceutical customers to ensure compliance and process improvements, as well as providing the focal point within the company for other industry standards and regulatory guidance. He came from a background in the Pharmaceutical industry and with software and consulting vendors, with over 30 years’ experience in software development and support of electronic submissions, publishing, and document. He is currently a Member of the HL7 Regulatory/Clinical Information Management group, and the IRISS Forum.
Abstract:
Regulatory submissions today fall under pretty strict standards: If it isn’t an eCTD (electronic Common Technical Document) it’s still likely to be based on the CTD, whether it’s electronic or not. Harken back to the days when publishing involved custom software; where a submission could mean shipping 150 pounds of equipment, or transporting multiple laptops across international boundaries; where reviewer demands could involve a 6AM phone call and a 7AM plane ticket. But it wasn’t all bad: the early days of electronic submissions resulted in an unprecedented level of interaction between reviewers and regulatory and led to our modern standards.
Keynote Forum
Manavalan R
RVS College of Pharmaceutical Sciences, India
Keynote: Pharma regulatory affairs as well as importance of ISO 9001:2015, ISO 14001:2004, ISO 18001:2007 standards and related audits for quality pharma products
Biography:
Manavalan R has pursued his PhD from Birla Institute of Technology and Science (BITS Pilani) Rajasthan, India. He is working as Professor and Research Director at RVS College of Pharmaceutical Sciences, Sulur, Coimbatore, Tamil Nadu which is a premier pharmacy school caters PG and Doctoral programme in Pharmacy. He has published more than 150 research papers in reputed journals. He has produced 33 PhD‘s in Pharmacy.
Abstract:
Regulatory affairs related legal acts are framed in various countries across the globe to manufacture and deliver quality products. They are Drugs and Cosmetics Act 1940 and amendments in India, United States of America Food and Administration Act, European Drugs Act and Australian Drugs Act. All address about Good Manufacturing Practices (GMP) and requirements to produce quality products. All they address about location and surrounding of the factory, building requirements for production under hygienic conditions, water supply for manufacture, disposal of waste, health, clothing and sanitary requirements for the staff, medical services, working benches for manufacture, requirements of facilities and equipment’s for various dosage forms (solid, liquid and semisolids), requirements of manufacturing areas and basic hygienic conditions, labelling, packaging and storage etc. All countries follow ICH guidelines regarding quality, safety and efficacy issues for easy import and export of goods among the countries. All factories should follow ISO 9001:2018 standards related to understanding of the organization and the context, developing Quality Management System (QMS), establishing quality policy, developing competency, documentation information, operational planning and control, requirements of products and services, design and development of products and services, identification and traceability, performance evaluation, internal audit, management review, non-conformity and
corrective actions and continual improvement. Getting ISO 9001:2015 certificate is an added value to pharma companies to ease import and export potential of quality products. Following ISO 14001:2004 standards in pharma companies indicate that the companies carry out the processes in such a way that lesser pollutants are produced (Environmental Management System). Following quality management system as ISO 18001:2007 (ISO Standards) indicate that occupational health and safety management systems are estabilished in the company. Following GMP guidelines and the above standards assure both regulatory affairs as well as various standards regarding quality management system, environmental management system as well as occupational health and safety management system. All will be addressed.