Gowning and ways to Avoid the common Sources of Contamination

In sterile combination, antiseptic technique is tributary to the bar of microbiological contamination. it’s providing sterility, safety, and effectivity to the sterile product, particularly varied injections for patients. Cleaning, Gowning and correct strategies of contamination management are reviewed along side why clean rooms square measure designed the manner they’re.

Why you have to Know:

Compounding sterile merchandise square measure created utilizing antiseptic technique. antiseptic technique could be a microbiological term concerning the interference of being contamination. The procedure involves the utilization of specialised instrumentation, sterile attire, meticulous process, and continuous improvement.

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This course can review correct improvement, gowning and ways in which to avoid the common sources of contamination that exist in an exceedingly room setting. This course is additionally a decent refresher for those personnel that ar accustomed to the thanks to properly add the room and why clean rooms ar designed for correct contamination management.

Register here for deep study

Who will be benefit from this:

  • This course will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts, in highlighting how to operate in a clean room environment, proper facility design, proper personnel gowning, and the equipment needed to conduct environmental monitoring
  • In addition, this course will review how Quality Systems help define requirements for aseptic technique and clean rooms and how to properly maintain these environments

About the Instructor:

Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

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Where’s Robotic-Assisted Surgery Headed?

Space for a great deal of mechanical innovation to help a wide broadness of surgeries.

Will Intuitive Surgical’s da Vinci framework be ousted as the business chief? Can one automated stage handle all medical procedures? Will self-sufficient robots take over in medical procedure? These themes and more were handled during MD&M East’s June 12 board exchange, “Mechanical Surgery – Visions of the Future.” Led by Shana Leonard, Informa Markets’ VP of substance, the board included Gianluca De Novi, PhD, CEO at XSurgical; Anthony Fernando, Chief Operating Officer and CTO at TransEnterix; and Dave Saunders, boss innovation officer at Galen Robotics.

“When you truly take a gander at the business, there’s likely 40, 50 careful robots that are in reality out there,” said Saunders. “Natural Surgical fills a specialty, and they make a great deal of cash doing it for stomach and urological medical procedures. There are bunches of things that the da Vinci does not and can’t do. . . . There are bunches of medical procedures that are unmistakable to how my innovation is upgraded that I don’t think da Vinci could ever be proper for either. What’s more, they don’t have an impetus to streamline their innovation for the sorts of regions I’m following since it would add up to overengineering. . . . What’s more, in the event that we take a gander at the ongoing securing of Auris by Johnson and Johnson, that robot completes a quite certain thing that is extraordinarily high effect, yet its utilization and utility is amazingly restricted. It’s sort of marvel medical procedure.”

In this way, “there is nobody innovation that is fitting for all things,” Saunders kept, including that the three automated stages from every one of the speakers “fill altogether different specialties. . . . Every robot is streamlined for the sorts of medical procedures that it needs to go into. What’s more, when you take a gander at the business, strengths are fragmented, so I’m following neurosurgeons, otolaryngologists, though you’re managing stomach medical procedures and general medical procedures,” he stated, addressing another specialist. “There’s simply various markets also regarding who’s obtaining the robots, so I feel all around emphatically that the business has a ton of development potential, and there is space for a great deal of mechanical innovation to help a wide broadness of surgeries,” he said.

“Rivalry drives advancement,” included Fernando of TransEnterix. “There’s a lot of space for different organizations to come in and contend. . . . There’s a chance to advance in various ways, and in medical procedure as well as numerous different partners you can please as a feature of presenting mechanical technology.”

“You have to include a specific level of curiosity,” De Novi said. “You truly need to make something that is powerful and dependable however . . . nobody else can do and patients can profit.”

As far as difficulties, the greatest could be repayment. “It’s extremely troublesome right now particularly in the U.S. since there aren’t a particular repayments that will enable you to do mechanical autonomy medical procedure. . . . You need to fit in the current financial model,” Saunders said. “So I need to construct a robot that has incredible utility for specialists, yet I must have something that fits into their financial aspects. What’s more, if that isn’t a thought forthright, the organization will have no footing.”

Notwithstanding tending to financial matters, mechanical autonomy organizations additionally need to drive proficiency. “Productivity should be calculated in light of the fact that it’s anticipated just in the U.S. a deficiency of specialists in the following 10 years. So whatever innovation, your apply autonomy should be essentially more effective than today so as to not feel any effect on the medicinal services framework overall,” Fernando called attention to.

For more info about Robotic-Assisted Surgery Headed

ESSENTIALS OF VALIDATION – Do You Really Need It?

The essentials of validation planning, protocol writing, and change management will be explained.

The criticality of validation to the Quality System Regulations and ISO 13485 can never be understated. Failure to validate attracts 483 observations from the FDA. Failure to validate has other consequences as well: it results in customer complaints, adverse events, and even product recalls. It thus bears no repetition that ingraining and implementing the essentials of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Validation are absolutely essential for regulated companies.

Which are the essentials of IQ, OQ, and PQ Validation that these regulated companies need to comprehend and implement into their Quality Systems? These highly valuable points will form the topic of a very crucial learning session that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing. Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session.

To register for this highly interactive and beneficial webinar on the essentials of IQ, OQ, and PQ Validation, which is being organized on April 30 and is of 90 minutes’ duration, please visit https://t2m.io/rR8THr4S.

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The core of the learning that Susanne will impart at this session on the essentials of IQ, OQ, and PQ Validation is on how to avoid the problems associated with improper IQ, OQ, and PQ Validation and to use validation concepts to ensure process stability and control.

At this course on the essentials of IQ, OQ, and PQ Validation, Susanne will explain the requirements that go into validation. She will give a thorough understanding of what processes need to be validated and what steps organizations in the regulated areas should take to validate processes. The essentials of validation planning, protocol writing, and change management will be explained.

V-Model-Development

This session will cover the steps for IQ, OQ, and PQ. The core of the learning on this area of this webinar are tips and best practices, the benefits and impacts of validation, and how participants’ customers and business can benefit from these. Also covered at this session on IQ, OQ, and PQ Validation are the tools and techniques that can help in successfully validating a regulated company’s processes.

This session will cover the following areas:

  • Purpose, scope, and benefits of process validation
  • FDA Expectations, Regulations
  • Lessons learned and enforcement case studies
  • Common problems
  • When to verify and when to validate
  • Process and steps for validation
  • Linkages to your Quality System
  • Master Validation Planning
  • Best Practices.

Professionals such as Manufacturing Engineers, Process Engineers, Quality Engineers, Engineering Managers, Quality Managers, Auditors, and Compliance Specialists will find this webinar on the essentials of IQ, OQ, and PQ Validation highly useful.

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About the speaker: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

Quick ways to learn Standard Operating Procedure

It does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

A Standard Operating Procedure (SOP) or a set of them is a sine qua non for organizations in the regulated industries. Yet, a lion’s share of the deficiencies that get detected during the FDA’s inspectional observations of organizations relates to problems in the SOP, for which these organizations get hauled up for enforcement actions.

However, the irony is that the blame for this situation lies with the FDA: while it mandates the need for SOPs among companies in the regulated industries, it does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

It is mainly because of the absence of these guidelines that many organizations come up with SOPs that fail to meet regulatory compliance guidelines. The most common areas in which they falter are the manner of their writing, communication, monitoring and enforcement. The SOPs that most organizations write either fall short of the details or miss the tools for ensuring compliance with the SOPs. Most of these SOPs contain errors that end up getting noticed only during an audit.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show the proper ways of writing SOPs in a manner that makes it easy for companies to maintain and update these and to also avoid punitive actions from the FDA. The speaker at this webinar is Todd B. Graham, a clinical laboratory scientist for a large hospital system in the New York Tri-State Area. Please register for this 90-minute webinar by visiting http://write.news/compliance_SOP

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At this session on quick ways to learn Standard Operating Procedure, Todd will explain a set of guidelines that will educate the participants on how to write SOPs and work instructions for FDA-regulated organizations. This will help participants with:

  • Becoming familiar with the basics of how to generate a great SOP
  • Understanding how to remain compliant and yet not restrict the course of action
  • Gaining knowledge of how to maintain the compliance over the course of the SOP lifetime.

At this highly valuable, well-rounded learning on the proper ways of writing SOPs and work instructions that befit FDA-regulated organizations; Todd will cover the following areas:

  • Record compliance with examples
  • What are SOPs?
  • Why are they important?
  • What are their benefits?
  • What are their limitations?
  • Important types of SOPs
  • Minimum number for SOPs, topics, and examples
  • SOPs and guidelines

 Steps to develop an SOP

  • Process mapping
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control)
  • An SOP example and template

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About the speaker: In his role as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities, Todd has helped organizations improve sample workflow and laboratory quality and reduce sample turnaround time. Through his work, he has also helped expand laboratory services to vulnerable health populations in the New York area. Another of his pursuits has been to offer outreach services to the local community by serving as a mentor to not only students training in clinical laboratory science, but also the scientific community, which he has done by serving as a technical resource for his peers in the laboratory.

Need More Time? Read These Tips to Improve [Pharmaceutical Clean Rooms]

HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

The proper and thorough understanding of the way in which a clean room’s HVAC system is designed and validated is critical for pharmaceutical professionals. This paves the way for creating the environmental control, a precondition for meeting the regulatory particulate and microorganism levels that are necessary for manufacturing a pharmaceutical product that meets quality expectations and requirements.

This makes environmental control of pharmaceutical clean rooms an indispensable element in the manufacture of a quality product. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain how to set the right conditions to obtain a cleanroom’s HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

This webinar, at which Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC will be the speaker, will be of 75 minutes’ duration and will be organized on March 18. To know more about how to improve pharmaceutical cleanrooms, please register for this webinar by logging on to https://t2m.io/Yn3dLyqB.

The main objective of this webinar is to underscore the criticality of the design, validation and ongoing monitoring of a clean room HVAC system in assuring both the quality and safety of the pharmaceutical product and to create a clean room environment that meets the compliance requirements set out by international regulatory standards.

Roger will explain Environmental Control vs. Environmental Monitoring, since the control of conditions such as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is vital to ensure the protection of the product from contamination.

He will also take up the various US and international regulatory requirements for various clean room classifications and then move on to comprehensive overview of the mechanics of clean room HVAC. He will reinforce the learning in this section by including engineering diagrams and schematics. Apart from detailing the HVAC equipment components and the automated control systems that are available, the speaker will also explain clean room design considerations. He will also emphasize the importance of proper building construction and layout for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

At this session, Roger will cover the following areas:

  • GMP Compliance of Clean Room Environment
  • Regulatory Clean Room Classification and Requirements
  • HVAC System Components
  • Clean Room Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Personnel Gowning and Aseptic Practices in Clean Room
  • HVAC System Validation.

This session is of high value and importance to professionals who work in cleanrooms, such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering and Maintenance.

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About the speaker:

Roger Cowan brings 37 years of experience in pharmaceutical quality assurance and manufacturing. His company specializes in consulting primarily in the area of pharmaceutical contract manufacturing. His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/International regulatory requirements, regulatory submissions, and quality assurance/control.

3-Hour Boot Camp for the Detection of Microbial Pathogens in Foods and Feeds

The session then describes how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.

All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

The presentation further describes evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.

Session #: 1
Duration: 1 hour
Learning Objectives: This section sets the context for the overall presentation and then provides validation criteria and guidance for all FVM-developed or any existing method(s) that has been significantly modified.
Introduction

  • Purpose & Scope
  • Administrative Authority & Responsibilities
  • General Responsibilities of the Originating Laboratory
  • Method Validation Definition
  • Applicability
  • Requirements

Criteria and Guidance for the Validation of FDA-Related Methods

  • Validation Definitions
    • The Reference Method
    • The Alternate Method
    • The Originating Laboratory
    • The Collaborating Laboratory
  • The Method Validation Process
    • Emergency Use
    • Non-Emergency Use
  • Validation Criteria
    • Validation Criteria for Qualitative Methods to Detect Conventional Microbial Food-borne Pathogens
    • Validation Criteria for Identification Methods
    • Validation Criteria for Quantifiable Methods to Detect
    • Conventional Microbial Food-borne Pathogens
  • Method Validation Operational Aspects
    • General Considerations
    • Assessment of Validation Results

Session #: 2
Duration: 1 hour
Learning Objectives: This session describes guidelines intended to support method validation efforts for developers of molecular-based assays e.g. PCR, to be used to confirm the identity of exclusion of isolated colonies. Methodologies from this session can be used for either conventional or real time PCR assays.

The session then describes how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.

Criteria and Guidance for the Validation of FDA-related molecular Based Assays

  • Inclusivity & Exclusivity
  • Target Genes & Controls
  • Comparison to the Reference Method

Criteria and Guidance for the Validation and Verification of Commercially Availbale Microbiological Diagnostic Kits and Platforms

  • Definitions
    • Validation of an Alternative Method
    • Verification
  • Criteria
    • Commercially-available Microbiological Diagnostic Kits Whose Performance Parameters Have been Fully Validated in a Multi- Laboratory Collaborative Study Monitored and Evaluated by an Independent Accrediting Body e.g. AOAC-OMA, AFNOR, etc.
    • Commercially-available Microbiological Diagnostic Kits Whose Performance Parameters are Supported by Data Obtained Through an Independent Laboratory Validation Protocol and Evaluated by an Independent Accrediting Body e.g. AOAC-RI

How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.