5-6 March 2025 - Sandton Convention Centre
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Strategnos Workstream

The Strategnos Workstream returns for SAPHEX 2025.

In Partnership with Strategnos

 - Fifteen Group

Achieving GDP Success: A Training Program on Key Aspects of Validation Management in Pharmaceutical Distribution

 

Achieving GDP Sucess: A Training Program on Key Aspects of Validation Management is designed to provide an in-depth exploration into several fundamental elements of pharmaceutical distribution compliance. This includes the Fundamentals of Cold Chain Management, where you will grasp the key components of cold chain management and its effect on the overall quality and safety of temperature-sensitive pharmaceutical goods.

In the Computer System Validation session, you will acquire knowledge on achieving dependable and efficient computer system validation, essential for maintaining process accuracy and consistency.

Through Transport Validation, you will comprehend the significance of validating transportation processes, a crucial step in preserving product integrity, and quality, and achieving regulatory compliance.

Lastly, in the Digital Quality and Validation Management segment, you will uncover how digital tools can streamline and enhance the management of quality and validation, minimizing errors and boosting productivity.

As a participant, this event offers you a chance to engage in comprehensive sessions led by industry professionals, providing you with invaluable insights into industry best practices. You will broaden your understanding of Cold Chain Management, Computer System Validation, Transport Validation, and Digital Quality and Validation Management intricacies.

You will be equipped with the most current industry information, a necessity for staying competitive in a rapidly evolving business landscape. Lastly, the training will aid in minimizing the risk of non-compliance, a factor that is increasingly important in the pharmaceutical industry.

Let’s facilitate compliance.

Agenda

06 March TimeTopicSynopsisSpeakerBio
10 mins09h30-09h40OpeningWelcome and OpeningScott Coleman
40 mins09h40-10h20Basics of Cold Chain ManagementCold chain management is an essential part of the pharmaceutical industry, ensuring product quality and safety from manufacture to end user. This training offers an introduction to cold chain management, covering critical aspects such as facilities, equipment, containers and vehicles, and the importance of temperature mapping and monitoring. The course also touches on significance of validation and qualification for a robust cold chain system.Sarantis Kosmas
Sarantis Kosmas is a highly experienced Supply Chain Management professional with over 15 years of experience in the field. He holds his Masters degree in Supply Chain Management of the Cold Chain. Sarantis has worked in a variety of industries including Pharmaceutical, Mining, Personal Care, Fashion Accessories, Food and Retail. He has a wide range of skills and accomplishments, including analytical and process thinking, strong interpersonal skills and publications. In 2011 Sarantis has published a paper on Validation of Cold Chain Systems in the South African Pharmaceutical Journal and presented at numerous conferences. Sarantis is the Business Development Director at Strategnos and continues a lead role in New Business Development.
40 mins10h20-11h00Computer System Validation Computer System Validation training provides comprehensive insights into the process of ensuring that all IT systems function as intended, meeting predetermined specifications consistently. The training emphasizes the significance of validation, regulatory compliance, methodologies to undertake successful validation, and the role of documentation in maintaining system integrity.Micaela CostaMicaela Costa is a Senior Systems and Test Analyst at Strategnos. She studied BCom Informatics at the University of Pretoria. Her knowledge and interest in the Information Technology industry have allowed her to create concepts that assist with solving business problems and providing solutions using systems. At Strategnos, Micaela specializes in system validation and assurance within regulated industries, ensuring that systems comply with regulatory standards and operate effectively. This involves assessing and verifying systems to ensure they meet quality, performance, and compliance requirements, which supports risk management and regulatory adherence across organizations.
10 mins11h00-11h10Q&A
30 mins11h10-11h40BREAK
40 mins11h40-12h20Transport VallidationTransport validation training equips participants with an understanding of the criticality of ensuring product integrity during transit. It covers key elements such as methodologies for validating transport processes, regulatory guidelines, risk management strategies, and the importance of temperature control and monitoring during transportation to guarantee product quality and safety.
Raveshnee MoodleyRaveshnee Moodley is a science graduate holding a Master of Science degree in Biology from the University of KwaZulu-Natal (UKZN). Raveshnee has an extensive background in the academic environment having experience as a teaching assistant/demonstrator/tutor and research assistant which provided the opportunity to collaborate with various established professionals. She presented her MSc research, which focused primarily on Tissue Culture, at the prestigious South African Association of Botanists annual conference (44th Annual SAAB Conference, 9-12 January 2018, University of Pretoria, Pretoria, South Africa).Raveshnee has a wide range of academic, scientific and practical skills. She meticulous, methodical and a critical thinker with an aspiration for knowledge. In her previous and current roles, she has been a mentor and project leader. Raveshnee is currently a Technical Consultant in the Temperature Management Solutions Division (i.e., Cold Chain Division) at Strategnos where she has developed a keen interest in Insulated Container Development in hopes to provide long term solutions to the cold chain industry.
40 mins12h20-13h00Total Cost of Cold Chain PackagingThe total cost of cold chain packaging incorporates various factors including the cost of insulated packaging materials, temperature monitoring, storage, transportation, validation and qualification. This also needs to account for the cost implications of regulatory compliance, quality assurance, and potential loss due to temperature excursions. The actual cost can vary significantly based on product specific needs, transportation distance, and environmental conditions.
Sarantis Kosmas
Sarantis Kosmas is a highly experienced Supply Chain Management professional with over 15 years of experience in the field. He holds his Masters degree in Supply Chain Management of the Cold Chain. Sarantis has worked in a variety of industries including Pharmaceutical, Mining, Personal Care, Fashion Accessories, Food and Retail. He has a wide range of skills and accomplishments, including analytical and process thinking, strong interpersonal skills and publications. In 2011 Sarantis has published a paper on Validation of Cold Chain Systems in the South African Pharmaceutical Journal and presented at numerous conferences. Sarantis is the Business Development Director at Strategnos and continues a lead role in New Business Development for both the Cold Chain and Supply Chain Consulting divisions.
10 mins13h00-13h10Q&A
90 mins13h10-14h40LUNCH
40 mins14h40-15h20Digital Quality & Validation
Management
Digital Quality & Validation Management highlights the integration of digital technology in upholding quality and validation processes. This includes understanding automated systems for quality management, use of digital tools in validation processes, ensuring regulatory compliance in a digital environment, and harnessing data analytics for decision-making, all while maintaining stringent data security and integrity standards.Sarantis KosmasSarantis Kosmas is a highly experienced Supply Chain Management professional with over 15 years of experience in the field. He holds his Masters degree in Supply Chain Management of the Cold Chain. Sarantis has worked in a variety of industries including Pharmaceutical, Mining, Personal Care, Fashion Accessories, Food and Retail. He has a wide range of skills and accomplishments, including analytical and process thinking, strong interpersonal skills and publications. In 2011 Sarantis has published a paper on Validation of Cold Chain Systems in the South African Pharmaceutical Journal and presented at numerous conferences. Sarantis is the Business Development Director at Strategnos and continues a lead role in New Business Development for both the Cold Chain and Supply Chain Consulting divisions.
10 mins15h20-15h30Q&A
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