Quick ways to learn Standard Operating Procedure

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

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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.

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.

INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

In fact, it was used to measure the blood oxygen of bomber pilots during World War II.

Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable downsides.

In being responsive to the physical and chemical environment of the dosage form: NIRS helps determine the potential values of API content, hardness, moisture, dissolution prediction, and degree of crystallinity. NIRS is valuable to the biopharma industry because, with its associated Chemometric software, is capable of monitoring, and also controlling, a bio-process.

NIRS enables a fermentation to have all its nutrients and by-products monitored simultaneously without consuming too much time for it the way traditional tests do. The use of NIRS is inestimable for medical research and investigations, since its penetrating radiation gives its users the opportunity to actually see through flesh and investigate the chemistry of a body in a non-intrusive and safe manner.

With its computational power and the ability to penetrate human tissue; NIRS is suitable for many kinds of bio-tests, tumor examination and many other such applications. In fact, it was used to measure the blood oxygen of bomber pilots during World War II.

At this webinar, the speaker will briefly review the theory and hardware available for near-infrared spectroscopy and show how and why it is good for the applications which it is put to. He will explain the many chemical and physical measurements of pharmaceutical (small molecule API) and biological (proteins, enzymes, bacteria) analytes. He will describe how the speed and specificity of NIRS allow these processes to be monitored and controlled in real-time to assure a quality product that is safe and effective.

At this session, which is of high value to Analytical & QC Chemists, Medical Researchers and Pharma Formulators; Emil will cover the following areas:

  • Types of NIR equipment used in each industry
  • Methodologies for pharma applications (sampling, software, validation)
  • Methodologies for biopharma
  • Methodologies for medical research.

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About the speaker:

Emil W. Ciurczak is the co-editor of the “Handbook of Near-Infrared Analysis” (4th edition in preparation) and co-author of “Pharmaceutical and Medical Applications of NIR Spectroscopy” (1st and 2nd editions). He has over 100 referenced publications and over 350 presented papers on the subject and is a Contributing Editor to Pharmaceutical Manufacturing and Contract Pharma magazines.

He won the 2004 EAS “Achievements in NIR” award was a member of the FDA’s subcommittee on PAT in 2002. He consults for pharma companies and instrument manufacturers.

The 3 Really Obvious Ways to Employee Success Better Than You Ever Did

This will help them to prioritize training items to both ensure compliance and reduce the learning curve for new or transferred employees.

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success” on February 6. Michael Esposito, a senior professional with rich experience in the pharmaceutical industry, GMP training and document management, will be the speaker at this webinar.

Please enroll for this webinar by visiting http://bit.ly/2GAxXos

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Onboarding can be quite a process for any organization; it is all the more so in organizations that function in a Good Manufacturing Practices (GMP) environment. This is because the FDA sets its own set of expectations and requirements for such organizations. These are set out in 21 CFR 211.25(a), under which parameters such as the education, training and experience to complete their job functions are described for pharmaceutical professionals.

Further, such organizations face questions regarding how to treat contractors, how to get HR to organize training for such employees, rules regarding the transfers for new employees, and so on. Thus, organizations face quite some daunting challenges when it comes to onboarding new or transferred employees in a GMP environment and ensuring compliance with these requirements.

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It is to help such organizations clear these confusions and questions that this webinar is being organized. Michael, who brings 30 years of experience in the pharmaceutical industry, of which 17 have been in GMP training and document management, during which he has worked with some very notable and prestigious companies; will bring this experience and help participants understand the issues concerning onboarding employees in a GMP environment. He will explain the three really obvious ways to employee success better than you ever did.

The areas he will over at this hour-long session include a bottoms-up of FAQs for employee onboarding, what expectations management should have for new employees, how HR should go about with the onboarding process, what role Quality has in the onboarding process, GMP training requirements, the rules governing handling full-time employees, contractors and other temporary personnel, and the benchmarks for training and competency. This will help them to prioritize training items to both ensure compliance and reduce the learning curve for new or transferred employees.

This session is of high value to employees that work in a corporate environment, such as Managers with Direct Reports, Human Resources Professionals, and Quality Assurance and Training Departments.

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About the speaker:

During the three decades that Michael Esposito has been a pharmaceutical and GMP training and document management specialist, he has worked in nearly all areas of the industry, including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations.

He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He has a keen interest in areas such as systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

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.