Quality Day for Pharma Industry
IPA is pleased to organize this live virtual one day course on Quality for Pharmaceutical Industry.
Date: May 12, 2022 | Time: 8:30 AM – 4:30 PM ET
Lunch Break: 12PM-1PM ET
Morning Break: 15mins
Afternoon Break: 15mins
Course Outline & Agenda:
8:30 – 8:45: Introduction of Presenters
8:45 – 10:00: Robust and Effective QMS in Multiple Regulatory Standards Environment
We are going to discuss common determinators of an effective Quality Management System (QMS) and the components of a robust QMS. We will discuss how to build a robust and effective QMS in multiple regulatory standards environment. A few tips for the inspection of your existing QMS will be provided. This is an interactive session that will include 2 case studies with concrete examples for a better understanding of a variety of situations.
Speaker: Natasha Demberg
10:00 – 10:15: BREAK
10:15 – 11:00: Long distance execution of qualification tests – How to be prepared?
Given the recent restrictions during the COVID19 pandemic, validation specialists and other pharmaceutical experts could not always travel to the manufacturing sites to execute the required qualification tests. Those tests had therefore to be performed long distance through a combination of local expertise and remote support from experts.
This presentation will explain the advantages and disadvantages of such an approach and will explain how to prepare for and how to manage long distance qualification execution of complex systems.
Speaker: Masa Ivankovic
11:00 – 11:45: Quality and Business Partnership – is it Possible?
We are going to discuss common challenges between Quality and Business, why those challenges are present, what are the indications of an ineffective relationship and what are the contributing factors. The ways to create efficient working relationships and the possible action plan, as well as the continuous improvement actions will be discussed.
Speaker: Natasha Demberg
11:45 – 12:00 Additional Question and Discussion
12:00 – 12:45 LUNCH BREAK
12:45 – 13:30: Qualification and validation consideration when acquiring used equipment
Qualification and validation consideration when acquiring used equipment
Because of the very high investment required to purchase pharmaceutical manufacturing equipment and systems, acquiring second hand equipment in good condition may be a good opportunity. However, the state of the equipment is not the only aspect to be considered when taking that decision. Often forgotten are software specifications, compatibility with other system, availability of spare parts or third-party service; all of which need to be research beforehand.
This presentation aims to list and explain several of the points to be considered to help make the best decision.
Speaker: Masa Ivankovic
13:30 – 14:30 Part I: Quality in the Modern Business Models. Third Parties Partnership – Outsourcing, Importation, Storage and Distribution
With increased volume of outsourcing and importation of pharmaceutical products a new approach to ensure product compliance must be considered. We are going to discuss different business models and different product supply chains, linear and hybrid Pharmaceutical Quality System. Also, the difference in QA activities to support in-house manufacturing, outsourcing and importation, and the combination of both will be discussed. How should Pharmaceutical Quality System reflect different business models and Supply Chain activities? What is an appropriate Quality structure in case of combined activities such as manufacturing and subcontracting/ importation? Should the structure be different from a standard one? At what point we must consider changing our QA structure and how to do so? The session will discuss Good Distribution Practice, storage, and appropriate warehouse qualification as an important step in product supply chain activities. Warehouse validation master plan and the validation steps will be presented and explained.
Speaker: Natasha Demberg
14:30 – 14:45: Break
14:45 – 16:00 Part II: Quality in the Modern Business Models. Third Parties Partnership – Outsourcing, Importation, Storage and Distribution
Speaker: Natasha Demberg
16:00-16:45: Q&A , Interactive discussion and closing remarks
Conclusion of Program
About the presenters:
Natasha Demberg, President, Demberg PharmaSolutions
Natasha Demberg is a Quality and BD Executive in the Life Science and Health Care industries such as Pharmaceutical, Cosmetics, Medical Devices, Natural Health Products, Cannabis, and Biotechnology. She has 30+ years in the development and application of Quality Management Systems throughout the product life cycle (development, scale-up, and commercialization) and Business Development for Pharmaceutical service providers. She is experienced in leading multi-functional groups to address challenging global regulatory compliance issues, develop strategy for Quality and Business Development, and create company culture oriented to Quality and Customer needs. Mrs. Demberg has Quality and Compliance expertise that spans cGMP compliance-Regulatory Bodies inspections, ISO and NIOSH certifications. Mrs. Demberg is an expert in PAI readiness, FDA and HC Mock Inspections, internal audits and suppliers and vendors audits and qualifications. As a BD executive Mrs. Demberg has an expertise of creating the client and business-oriented company culture, efficient customer support and services.
Currently, Mrs. Demberg is the leader of Demberg PharmaSolutions (DPS) consulting company that provides Quality & Compliance, consulting services for firms in the Life Science and Health Care industries for medical devices, pharmaceutical, cosmetic, cannabis, natural health, and investigational products. . DPS helps their clients in the creation of an efficient QMS that supports the business needs, DPS also performs thorough internal investigations, CAPAs and Deviations. In addition to Quality & Compliance, DPS works with all the departments to create a quality and business-oriented company culture and align objectives to the client’s business needs.
Natasha is known for her dynamic leadership style and her ability to think strategically and outside of the box. She brings with her the tremendous mix of technical expertise, regulatory knowledge, and her business sense. Due to her ability to operate on an executive level she brings together business and quality and develops a common language between the two.
Mrs. Demberg’s career has included a wide range of successful leadership positions in Quality Organizations of several companies in the pharmaceutical field. Initially as a chemist at Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Confab Laboratory Director of Quality Operations, Vice President of Quality Operations at Valeant Canada and Vice President of Operations and Pharmaceutical Solutions at Neopharm Labs, and many others. Currently Natasha is the Founder and President of Demberg PharmaSolutions (DPS).
Natasha holds a BSc in Chemical Engineering, a MSc in Chemistry of Polymers, Six Sigma Green Belt Certification, and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.
Natasha is an Industry Speaker on Quality and GMP Compliance in the Life Science Industry, program of Pharmaceutical Technology at John Abbott and various GMP conferences and seminars.
Masha Ivankovic, eng.
Masha has more than twelve years of experience in the pharmaceutical and biotechnology industries, in Canada, the United States and in Europe. Having started her career as a validation specialist in the pharmaceuticals injectables industry, she has pursued her professional path in the field of consulting. This gave her the opportunity to cover a wide range of mandates in engineering, validation and project management in the life sciences industries.
Masha opened an engineering and consulting firm in 2018, which has since grown to successfully support smaller and large projects in the Montreal area.
Masha holds a Bachelor degree in science from McGill University, a Bachelor in chemical engineering from Ecole Polytechnique de Montreal and an MBA from McGill University and is a member in good standing of the Ordre des Ingenieurs du Quebec.
Registration Fees:
Early Bird, Register by April 8: $499 + HST
One Day Registration: $599 + HST
