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.

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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.

Learn Exactly How I [Improved Security] Risks in the Supply Chain

He will impart the knowledge needed for understanding the centrality of information system security in the supply chain.

Compliance4All, a reputable provider of professional training for all the areas of regulatory compliance, is organizing as webinar on the topic, “Identifying Information Security Risks in the Supply Chain” on February 25. Robert E. Davis, a senior information systems security specialist, will be the speaker at this webinar.

Please log on to https://t2m.io/y8kuD5MV to enroll for this webinar.

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Connectivity, which encompasses both the cultural and the physical aspects, forms an organization’s backbone. These two elements should be melded into the organization seamlessly. The organizational culture, the firm’s intangible factor, is the basis to nurturing an environment in which there is continuous and efficient collaboration and teamwork across the many processes, functions and departments. This well-oiled mechanism should also ensure compliance with the processes and regulations and should handle customers, while bringing about continuous process improvement.

Integration of the external factor, consisting of the supply chain, and the internal factor, in which business processes strategies are central, is something all organizations should strive to achieve. The supply chain should dthus help the organization derive value. Organizations typically design and deploy supply chain process integration to achieve specific objectives while imbigin best-practice solutions at the same time, aimed at reducing inappropriate or poor responses to environmental conditions.

At this webinar, the speaker will show how to implement standards and best practices into the supply chain by quoting real-life examples. He will show how employees can take steps and processes for initiating, documenting and compiling supply chain security risks. He will impart the knowledge needed for understanding the centrality of information system security in the supply chain.

Robert will cover the following areas at this webinar:

  • Forces Affecting the Supply Chain
  • Information Security Principles
  • Information Security Practices
  • Strategic information Risk Considerations
  • Tactical information Risk Considerations
  • Operational information Risk Considerations.

This webinar is of value to Risk Management Personnel, External Auditors, Internal Auditors, Supply Chain Professionals, Information Officers, Compliance Assessors and Information Security Officers.

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About the speaker:

Robert E. Davis is an invited Golden Key International Honor Society member. He is a Doctor of Business Administration student specializing in Information Systems Management at Walden University. As a seasoned information systems (IS) auditor, Robert has provided data security consulting and IS auditing services to the United States Securities and Exchange Commission, United States Enrichment Corporation, Raytheon Company, United States Interstate Commerce Commission, Dow Jones & Company and Fidelity/First Fidelity (Wells Fargo) corporations, as well as other organizations.

The Secret to Mastering Calibration in Just 60 Minutes

Validation needs to be done prior to putting the equipment to use. This is done to ensure that the product that is being produced meets its specifications.

Compliance4All, a reputed provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Equipment Validation, Tracking, Calibration and Preventive Maintenance” on February 22. Jeff Kasoff, Principal Consultant at Lean to Quality, LLC, will be the speaker at this webinar.

Please enroll for this valuable learning session by visiting http://bit.ly/2BUT7JY.

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For both the FDA and the EU, calibration and maintenance of test and measurement equipment is a regulatory requirement. The FDA mandates this under 21 CFR Part 210 and 211 and the EU has its own set of regulations that stipulate compliance to their respective programs for medical device manufacturers.

It is to ensure these among others that the equipment validation program has been put in place by these regulatory bodies:

  • The reliability and capability of the equipment to perform the function and use to which it is put
  • Its safety
  • The unhindered and free flow of work done by it
  • Obviating the need for the manufacturer to invest hugely on making premature replacements of the equipment
  • Keeping the cost of making it at the lowest.

An equipment calibration program should consist of these:

  • Intervals
  • Scheduling
  • Specific procedures
  • Limits of accuracy/precision, and
  • Remedial action when the equipment does not meet established requirements.

Main elements of equipment validation

The EU and the FDA require equipment validation to be done from these perspectives:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Change control & Requalification

Validation- before and after use

Validation needs to be done prior to putting the equipment to use. This is done to ensure that the product that is being produced meets its specifications. Also, methods by which equipment that are already in use have to be validated are also suggested.

A complete understanding of all the aspects of calibrating and maintaining test and measurement equipment

At this webinar, Jeff will describe all the aspects of equipment validation, tracking, calibration and preventive maintenance. He will offer incisive clarity on planning and implementing a program that meets all the regulatory requirements relating to the validation and maintenance of test and measurement equipment.

Participants will understand how to calibrate and maintain test and measurement equipment. All the elements going into it, such as intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action when the equipment does not meet established requirements, will be explained. The expert will also offer a heads-up on how to validate equipment already in use.

This session is of immense value to those who work with equipment/process development. These include:

QA management, Quality Engineering staff, R&D management, Engineering management, Production management, Manufacturing Engineering staff, Design engineers, Reliability engineers, Calibration technicians, and Maintenance personnel.

This webinar will cover the following areas:

  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification
  • Preventive Maintenance Requirements
  • Calibration vs. Maintenance: When to use Which One?
  • Remedial Action for Out-of-Calibration Equipment
  • Use of Calibration Standards to Save Cost
  • Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

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About the speaker:

Jeff has implemented and overseen Quality System operations and assured compliance at companies that have ranged from startup to those that earn over $100 million in revenue. In addition, Jeff has also been a primary liaison with FDA inspectors and notified body auditors, which has given him hands-on experience with the most likely tricky issues that the regulatory agencies face. This varied experience makes him uniquely qualified to address compliance issues across a broad range of company sizes and specializations.

http://bit.do/dspNR

Trial Registration and Results Reporting on ClinicalTrials.gov

Guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).

The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry.

The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

In this session we will review the challenges clinical teams and sponsoring organization face in determining if a clinical trials are qualified and required to be registered, and discuss time frame for updates to be posted and reporting of the results to be completed.

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results.

Registration and summary results reporting of clinical trials has two main purposes: to inform potential subjects, and to increase transparency of conducted clinical trials and the likelihood that negative results of trials will be publicized. The U.S. Government site for registering clinical trials is ClinicalTrials.gov. A study is issued a CT.gov NCT registration number when it is registered. A trial only needs to be listed once.

For investigator-initiated clinical trials, the Principal Investigator is considered the Responsible Party, and is the one who has to complete the registration. For multi-center clinical trials, someone other than the local PI usually fulfills this responsibility (i.e. the Sponsor).

The Responsible Party who initially registered the clinical trial is also the one who must maintain the information about the trial, including updating recruitment information at least every 12 months and reporting final results.

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices.

The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

  • Discuss key factors to consider, when deciding if its qualified clinical trial
  • Review rules, policies and guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports
  • Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov”in NEJM (Nov. 2016)
  • Provide overview of registration process on Clinicaltrial.gov website
  • FDA’s expectation for clinical site and sponsor’s essential regulatory documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common discrepancies in TMF management

What do Your Customers Really Think About Your Complaint Handling?

How companies in these industries should set up their complaint handling systems.

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

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

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A complaint says a lot about a product. It helps the manufacturer to reflect on where it could have gone wrong. A complaint handling system is the antidote to complaints. A proper complaint handling system gives the manufacturer a proper idea of how its products are perceived in the market and how well it can respond to consumer requests. In areas such as medical devices and pharmaceuticals among others, the FDA has set out its requirements on how companies in these industries should set up their complaint handling systems.

GMP requirements have been set out for internal complaint handling for the GMP-governed areas. At this webinar, the speaker, Peggy Berry, will address approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. She will address the various aspects of the review process, SOP preparation, investigation documentation, and the crucial aspect of how to respond to complainants. She will offer insights into what do your customers really think about your complaint handling.

Participants of this webinar will be able to set up effective internal systems to receive, investigate and respond to product complaints during both the investigational and commercial stages. Peggy will review of GMP requirements for complaint handling and explain the types of complaints that an organization may expect to receive.

She will show how to track the complaint from the time it is received and how to initiate and perform a complaint investigation. She will also show how to review the complaint and investigation and how to prepare a response to the complainant, as well as how to prepare an associated SOP.

This crucial webinar on putting in place an effective internal complaint handling system that ensures compliance with GMP requirements is of value to professionals in the areas of Manufacturing, Clinical Operations, Quality Control, Quality Assurance and Regulatory Affairs.

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About the speaker:

Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.

Risk Management for Medical Devices – ISO 14971 2007

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.

During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or to the environment during all stages of a product’s life cycle and supply chain.

Risk management is a process that involves many considerations, responsibilities, personnel, and the transfer of knowledge. Given that it transcends projects and even companies, it is particularly critical that key pieces of information survive these many hand-offs.

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.

  • Risk management process as per ISO 14971
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file
  • Bringing it all together –links to design and process

 

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