7 Essential Trainings about a Comprehensive Review of Biotechnology Industry

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.
Instructor: Tim Sandle & Carl Patterson
Product ID: PACK70072

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

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

Webinars included in the Package:

Investigating Sterility Test Failures (Duration: 60 Minutes)

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.

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

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

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.

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

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

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. 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.

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

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

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.

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

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

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products (Duration: 60 Minutes)

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. 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, and means of mitigation and methods of detection.

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

Instructor Profile:

Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

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. 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

Instructor Profile:

Carl Patterson, M.S has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields.

Price:$700.00
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