Pharmaceutical, Laboratory & Research

This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or working under Good Laboratory Practice regulation for the first time. The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems.

The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will be presented.

Benefits of attending includes:

  • Sound regulatory basis for quality assurance activities
  • Clear understanding of the role of Quality Assurance, Management and Study Director under the Good Laboratory Practice principles
  • Improved inspections and audits
  • Improved Good Laboratory Practice compliance for your facility
  • An insight into government GLP monitoring activities.

This course is structured to encourage delegates to:

  • Discussand develop ideas
  • Solve specific problems
  • Examine particular aspects of GLP

FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).

LEARNING OBJECTIVES

  • The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA- regulated products, and finished FDA- regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
  • Laboratory organization, personnel qualification and training requirements.
  • Documentation and record- keeping requirements, including e- records and data integrity.
  • Sample integrity requirements.
  • Management and control of stability (shelf- life) studies
  • Analytical methods verification and validation.
  • Management and control of laboratory instruments.
  • Management and control of laboratory supplies.
  • Proper conduct of laboratory investigations.
  • Consequences of laboratory non- compliance.

Employers play an important role in creating workplaces that are inclusive of individuals with disabilities. Formal and informal organizational policies and practices are a key component of what determines whether a workplace is or is not disability-friendly. People with disabilities are largely an untapped resource in the labour market despite the fact that they have immense potential to contribute meaningfully to society and to the business sector in particular. This potential needs to be converted into positive action where people with disabilities have an equal opportunity to contribute and be rewarded for their inherent worth. There is a sound local and international legislative framework for the employment of people with disabilities. Employee recruitment and retention of disabled people has emerged as one of the primary challenges facing employers today. More so than ever before, employers need to develop and implement effective human resource strategies to find and keep the employees they need to complete in the global market place.

Benefit of attending

  • Communicate benefits and rights of persons with disabilities in the workplace.
  • Facilitate equitable representation of persons with disabilities in the workplace.
  • Conduct interventions to remove barriers to persons with disabilities in the workplace.
  • Know, understand and apply relevant legislation
  • Manage talent with regards to the recruitment and retention of people with disabilities

Root cause analysis is a problem solving process for conducting an investigation into an identified incident, problem, concern or non-conformity. Root cause analysis is a completely separate process to incident management and immediate corrective action, although they are often completed in close proximity. Root cause analysis (RCA) requires the investigator(s) to look beyond the solution to the immediate problem and understand the fundamental or underlying cause(s) of the situation and put them right, thereby preventing re-occurrence of the same issue. This may involve the identification and management of processes, procedures, activities, inactivity, behaviours or conditions. Laboratories often experience recurrence of non-conformances which sometimes results in them being suspended or test methods being removed from accreditation scope. Without an effective root cause analysis, laboratories face a certainty of recurring non-conformances thus wasting company resources.

Root cause Analysis Workshop ensures that laboratories effectively identify and address the root cause of the problem. By outlining different methodologies and practical laboratory related examples of root cause analysis, laboratory personnel can surely improve their management system and technical services. This science-based investigation methodology integrates problem solving techniques from total quality management (TQM), Six Sigma, and generic problem solving approaches to identify the technical root cause (the change that has occurred) as well as any systemic root causes (system failures that allowed the change to occur). Corrective and / or preventive actions are then taken so that the performance can be restored to its previous, professional level. A control plan is then implemented to prevent the problem from ever returning.

WHO SHOULD ATTEND ?

This highly practical workshop for Laboratory analysts, professionals in Quality, Senior and Middle Level Managers from Laboratories of any type and size (QC Labs, Medical/Hospital Labs, Pharmaceutical and Food industries Labs, Laboratory Technicians, Quality Assurance Managers and Senior Personnel Health and Safety Manager, Supplies Acceptance Labs, In-process Labs.

Water is one of the most important raw materials in the manufacture of pharmaceutical products. In order to produce water of an appropriate quality, water systems have to fulfill considerable requirements, which are partly set out in detail in the relevant pharmaceutical regulations. Although the characteristics of pharmaceutical waters are sufficiently defined, a large number of questions remain unanswered as regards to the technical implementation of these bodies of regulations in GMP- conform water systems.

The main focus of the course ʻPharmaceutical Waterʼ is therefore on how to put these requirements into practice. In their lectures, experienced specialists will give you important information and support for your own projects and systems, ranging from regulatory requirements, design, qualification, validation and routine operation.

Objectives
The objective of this intensive education course is to enable the participants to pay optimal attention to critical issues during design, qualification and routine operation of pharmaceutical water systems.

You will learn:

  • How to meet the pharmacopoeial requirements
  • How to find the critical design aspects in a water system
  • How to generate pharmaceutical water and steam in the desired quality
  • How commissioning and qualification is done today
  • How microbial validation and control is achieved
  • How the systems is maintained in a controlled status during its life cycle

Food Development and Innovation has evolved from the successful and long-running Food and Consumer Management course.

While the core values of the previous course have been retained, it has been enhanced to reflect the development of our Food Science and Innovation Suite and feedback from the industry. The course combines up-to-date technical knowledge with the practical skills required by the food industry. 

Innovation and creativity in food development is crucial if the industry is to meet the challenges posed by a diverse market and changing consumer trends. Technology is constantly evolving to meet the demands of a nutritious, safe and sustainable food supply. 

This course is designed for individuals who are seeking a management career in the food, beverage and retail industries. The food industry is diverse, consisting of small and niche businesses, blue chip manufacturers and major retailers. Additionally, this course is designed for those interested in food media and food technology education.

Why should I choose this course?

  • You will learn about food commodities, nutrition and food safety through practical application and development work.
  • You will examine current trends within the industry such as health, food availability, food security and the rise in food costs.
  • Your employability will be enhanced by the opportunity to work for a year in industry and additional work placement options.
  • You will get the chance to work in our new Science and Food Science and Innovation Suite, which features the latest food testing and diagnostic technology alongside state-of-the-art development kitchen facilities.
  • Well-developed links with industry are reflected in the design and delivery of this course. Industry-led projects and assignments have a strong industrial focus ensuring students experience real live projects.

Why Attend?

A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)- compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP- compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on- going training/ development of personnel will also be covered. Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality- critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.

Course Objectives

By the end of the course, participants will be able to:

  • Explain the importance of Good Manufacturing Practices (GMP) in ensuring patient safety and drug efficacy
  • Apply US- compliant pharmaceutical standards to enhance the current pharmaceutical quality management system within their own organization
  • Find and continuously implement the current GMP requirements and updates frequently released by US authorities
  • Implement pharmaceutical data integrity regulations
  • Produce GMP- compliant documents, records and written procedures
  • Prepare for regulatory inspections as well as internal and supplier audits

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