7 Essential Trainings for Biotechnology Industry

Product ID: PACK70072

Instructor: Tim Sandle & Carl Patterson

This set of courses provides you with wide variety of areas in the Biotechnology industry including Sterile Product Manufacturing & Testing, Contamination control, risk within the manufacturing process and also auditing for potential sources of contamination. Also guide you with best methods to detect and mitigate any issue which poses a threat.

Webinar Topics Included:

  • Investigating Sterility Test Failures
  • EU GMP Annex 1 – What’s New for Sterile Product Manufacturing?
  • Fungal Contamination and Pharmaceutical Products Recall
  • The Problem of Bacterial Spores and Sporicidal Disinfection
  • Human Microbiome and Implications for Contamination Control
  • Burkholderia cepacia – Risks in Context for Non-Sterile Pharmaceutical Products
  • Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
1. Investigating Sterility Test Failures (Duration: 60 Minutes)

Sterility testing is widely used in both the medical device and pharmaceutical industries. The pharmacopeia test is the official procedure for testing the sterility of pharmaceutical products. Despite its importance and its widespread use, many people are not aware of the limitations of the sterility test and are unsure how to proceed when a failure investigation occurs.

Questions to help with this process, like — “Can the test be invalidated? Is the product rejected? What needs to be investigated? How is root cause established? What need to be done before production can resume?”– will be answered in this webinar.

Objectives of the Presentation

  • What the sterility test can and cannot demonstrate
  • The causes of sterility test failures
  • The actions required on being notified of a failure, including deviation management and quarantine
  • Best practices for laboratory test investigations
  • Best practices for processing investigations
  • Best practices for aseptic processing investigations
  • Developing a remediation plan including the necessity for media simulation trials

Why Should you Attend
To gain an insight into the best practices for sterility test failure investigations, from a speaker who has presented sterility test failure investigation reports to both FDA and European Medicines Agency inspectors.

Areas Covered

  • History of the sterility test
  • Statistical limitations of the sterility test
  • Actions required by management on being notified of a sterility test failure
  • The importance of genotypic microbial investigation
  • Points to consider for investigating testing, such as cleanroom or isolator operational parameters
  • Reviewing major contamination incidences in process areas that could lead to a sterility failure, from raw materials to wet equipment
  • Detailed forensics for aseptic process investigations, such as reviewing people, processes and equipment
  • How to do put an investigation report together
  • How to test out CAPA through media fills
  • What to do if the investigation is inconclusive

Who will Benefit

  • Microbiologists (QA and QC)
  • QC managers
  • Production managers
  • Quality Assurance personnel
  • Operational excellence personnel
  • Engineering managers

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

2. EU GMP Annex 1 - What's New for Sterile Product Manufacturing? (Duration: 60 Minutes)

A major revision is taking place with the European regulations covering the manufacture and distribution of sterile products. This is the first major update in 20 years, with the new draft text bringing in many changes, several of which will be far reaching.

Objectives of the Presentation

  • What the new Annex 1 contains and what it excludes
  • What are the differences between the new requirements and previous requirements
  • The relationship between the Annex and ISO 14644
  • Understanding microbiological risks
  • Understanding what is required for a contamination control strategy
  • New emphasis on quality risk management

Why Should you Attend
To learn about the considerable number of changes made to sterile products manufacturing changes that are forthcoming. Although the Annex is applicable to Europe, it was written in conjunction with U.S. FDA and it signals the latest developments with global regulatory thinking.

Areas Covered

  • Sterile products manufacture
  • Aseptic processing
  • Sterilization
  • Environmental monitoring
  • Microbiology
  • Contamination control
  • ISO 14644
  • Cleanroom classification
  • Corrective and preventive actions for contamination incidents
  • Quality risk management

Who will Benefit

  • Production managers
  • QA
  • QC
  • Microbiology
  • Regulatory personnel
  • Business intelligence

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

3. Fungal Contamination and Pharmaceutical Products Recall (Duration: 60 Minutes)

Over the past decade, the number of pharmaceutical product recalls due to fungi has increased significantly, with many different product groups affected. Data suggests a link between product contamination and the process environment. A key concern is a lack of knowledge, even among microbiologists, about identifying fungi and understanding their origins. This webinar will explain different types of fungi, risks to products, guidance on identification, and a focus on remediation measures to remove, eliminate and to prevent fungi.

Objectives of the Presentation

  • To learn about fugal risks
  • To appreciate the extent of pharmaceutical product recalls relating to fungi
  • To understand which types of medicinal products are most at risk
  • To learn about the common types of fungi associated with cleanrooms
  • To understand the main points of contamination
  • To learn about monitoring techniques
  • To learn about good disinfection practices
  • To understand other remediation activities

Why Should you Attend
In this webinar speaker will examine the risks posed by fungi to pharmaceutical products and has emphasized how this is an issue of growing importance (as seen by the extent of product recalls relating to fungal contamination). The webinar has further considered where fungi pose a risk within the manufacturing process and also to argue that recalls relating to fungal contamination can be reduced through improved cleanroom design; risk assessment; and developing greater specialism’s within quality control departments in order to be able to characterize, identify and to trace fungi. This way, the risks posed by fungi to pharmaceutical processes should receive the level of attention necessary, especially in light of the potential for certain products to become contaminated.

Areas Covered

  • Trends in pharmaceutical product recalls due to microbiological and fungal contamination
  • FDA and other regulatory concerns
  • Risks posed by fungi in cleanrooms
  • Types of fungi
  • Environmental monitoring methods
  • How to kill fungi
  • How to identify different types of fungi
  • How to design facilities to avoid fungal contamination
  • Good remediation practices

Who will Benefit

  • Production managers
  • Microbiologists
  • Quality Assurance
  • Production staff
  • Maintenance / engineer staff
  • Medical staff
  • Pharmaceuticals – sterile and non-sterile
  • Medical devices
  • Biotechnology
  • Healthcare
  • Academia

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

4. The Problem of Bacterial Spores and Sporicidal Disinfection (Duration: 60 Minutes)

There have been a number of pharmaceutical and healthcare product recalls associated with bacterial contamination, and a number of these are associated with spore forming organisms. In addition, there have been some reported cases of patient illness, especially in relation to aseptically produced medicines. Investigations have shown that poor contamination control has led to spores being prevalent in the production environment. Improved contamination control strategies are required to prevent such incidents from occurring.

Objectives of the Presentation

  • Understanding of bacterial spore risks
  • Understanding of how bacterial spores survive
  • Understanding of the risk factors that can introduce spores into the cleanroom
  • Understanding of disinfection
  • Understanding of the difference between standard disinfectants and sporicides
  • How sporicides kill spores
  • The importance of a holistic contamination control program

Why Should you Attend
Incidents of bacterial spore contamination of medicinal products are increasing. Regulators are concerned about the link between product recalls and the process environment. Pharmaceutical and healthcare facilities need to have a robust biocontamination control program in place. This webinar outlines the origins and risks of spores, strategies to reduce incidents, and the selection and incorporation of sporicidal agents into the contamination control program.

Areas Covered

  • Introduction to bacterial spores and the spore lifecycle
  • Sources of spores in cleanrooms
  • Control strategies to minimize spores
  • Introduction to disinfectants, and How disinfectants work
  • The process for selecting sporicidal agents
  • Qualifying sporicides
  • Incorporating sporicides into the contamination control program
  • Troubleshooting

Who will Benefit

  • Production managers
  • Microbiologists
  • Quality Assurance
  • Production staff
  • Maintenance / engineer staff
  • Medical staff
  • Pharmaceuticals – sterile and non-sterile
  • Biotechnology
  • Healthcare
  • Academia

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

5. Human Microbiome and Implications for Contamination Control (Duration: 60 Minutes)

People are the biggest source of contamination in cleanrooms. The findings from the human microbiome project suggest an overview of controls is required. This presentation reviews the latest research into the human microbiome, especially in relation to the skin, and looks at the levels of controls and risks required, such as behaviors and gowning practices. The presentation also considers the impact of the knowledge on the use of environmental isolates for culture media testing and applied areas like disinfectant efficacy testing.

Objectives of the Presentation

  • To understand the latest research on the human microbiome
  • To learn about the reasons for microbial survival in people and in cleanrooms
  • To understand the types and ranges of microorganisms on human skin, and how these relate to objectionable organisms
  • Review staff gowning and personnel behavior in pharmaceutical cleanrooms
  • Consider good glove sanitization practices
  • Learn how cleanroom risk can be minimized
  • Review training for all cleanroom staff
  • Look at the use of environmental isolates for media and disinfectant efficacy testing

Why Should you Attend
To understand the complexities and challenges that people pose to cleanroom environments and to consider the controls required to minimize contamination impact.

Areas Covered

  • The human skin ecosystem
  • The Human Microbiome Project and the microorganisms found in association with both healthy and diseased humans. How the human microbiome research has impacted on cleanroom activities including gowning practices
  • Selection of cleanroom garments like fabric types, garment lifespan, recycling, laundering, human changing procedures, training, behavior, hand sanitization, ongoing assessments, and associated topics

Who will Benefit

  • Engineers
  • Lecturers
  • Production managers
  • Microbiologists
  • Quality Assurance
  • Production staff
  • Maintenance / engineer staff
  • Medical staff
  • Pharmaceuticals – sterile and non-sterile
  • Biotechnology
  • Healthcare
  • Academia

Topic Background
Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. This is, in some way, evidenced from the association of microorganisms transient or residential to a skin being the primary isolates from environmental monitoring in controlled environments. Human personnel shed high numbers of skin cells mostly as skin flakes. The cleanroom garments worn by personnel cannot contain all human detritus. How effective are these controls in relation to new insights into the human microbiome?

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

6. Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products (Duration: 60 Minutes)
Burkholderia cepacia complex (BCC) organisms can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents. This makes the organism a risk in terms of non-sterile aqueous products. Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. This webinar discusses where the organism may be found, how to detect it and what to do if it is present in the manufacturing environment.

Objectives of the Presentation

  • The origins of Burkholderia cepacia in pharmaceuticals and healthcare
  • Risks to patients
  • The link to pharmaceutical product recalls
  • The need to design a testing regime
  • The use of rapid methods for detection
  • Strategies for method validation
  • The importance of a holistic contamination control strategy

Why Should you Attend
Drug manufacturers of non-sterile, water-based drug products have seen recent product recalls due to Burkholderia cepacia complex. Regulatory agencies expect pharmaceutical manufacturers to be testing environments, water and products for the organism and putting remedial measures in place. In order to test effectively, microbial methods need to be suitably qualified. The qualification of methods is challenging. Attend this webinar to learn more about this microorganism of concern, and to learn about its origins, risk factors, means of mitigation and methods of detection.

Areas Covered

  • What is Burkholderia cepacia?
  • Patient risks
  • Product recalls
  • Where Burkholderia cepacia is found in the pharmaceutical environment?
  • How to test for the organism, using conventional and rapid methods
  • How to qualify methods
  • Remediation strategies should contamination occur
  • The need for a contamination control strategy

Who will Benefit

  • Quality assurance
  • Quality control
  • Production managers
  • Medical staff
  • Infection control
  • Microbiologists
  • Engineers
  • Lecturers
  • Production managers
  • Production staff
  • Maintenance / engineer staff
  • Pharmaceuticals – sterile and non-sterile
  • Biotechnology
  • Healthcare
  • Academia

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.

7. Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing (Duration: 60 Minutes)
The webinar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.

Objectives of the Presentation

  • Provide background information on what microbiological aspects to audit for
  • What international regulations should be referenced
  • ISO classification of rooms and how it should be applied
  • Product bioburden and why bioburden is important.
  • Validation and qualification of bioburden and manufacturing suites.
  • Key sources of microorganisms and why this is important
  • What the source means in terms of root cause

Why Should you Attend
The risk of non-compliance related to microbiological causes is too great, in terms of fines, potential law suits, loss of consumer confidence and ultimately, the bottom line. This means that biopharmaceutical manufacturers must prove that their facilities and products are free from contamination.

This webinar is designed to help organizations understand that preventing microbial contamination is the responsibility of everyone in the organization, and that everyone must play a part in it. Attendees will learn how to create a robust inspection program that includes auditing for potential sources of microbial contamination.

Areas Covered

  • International regulations (ISO)
  • Federal regulation (FDA, USP)
  • Room classifications and how applied to manufacturing
  • Auditing company environmental programs for effectiveness
  • Reviewing of documents in relation to microbial aspects
  • Sources of common microorganisms
  • Identify root causes for many microbiological excursions

Who will Benefit

  • Personnel involved with observing aseptic processing operations
  • Quality assurance personnel
  • Quality control personnel
  • Microbiology professionals
  • Validation
  • Manufacturing
  • Quality system auditors
  • Warehouse managers
  • Facilities/maintenance
  • Regulatory and compliance management
  • All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported

Instructor Profile:
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor’s of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master’s of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.

$500.00

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How It Works:

  • Recorded sessions will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Links are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Reference materials for Webinar Recording will be mailed to your registered e-mail id

Who will benefit?

  • Microbiologists (QA and QC)
  • QC managers
  • Production managers
  • Quality Assurance personnel
  • Operational excellence personnel
  • Engineering managers
  • QA
  • QC
  • Business intelligence
  • Maintenance / engineer staff
  • Medical staff
  • Pharmaceuticals – sterile and non-sterile
  • Medical devices
  • Biotechnology
  • Healthcare
  • Academia
  • Engineers
  • Lecturers
  • Production staff
  • Personnel involved with observing aseptic processing operations
  • Quality control personnel
  • Microbiology professionals
  • Validation
  • Manufacturing
  • Quality system auditors
  • Warehouse managers
  • Facilities/maintenance
  • Regulatory and compliance management
  • All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported

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