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.

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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.

Basic Supply Chain Food Safety Control Requirements 2019

With the finalization of the FDA’s FSMA Preventive Control Rules, new FDA outbreak testing technologies and increasingly complex supply chain controls, spices and other low moisture foods are becoming increasingly identified as outbreak contributors.

Spices are frequently found to carry salmonella, are full of physical adulterants, are often not identified as allergens, may be impacted by lead and, when not carefully controlled throughout the supply chain, represent a bacterial growth potential that can end up in processed foods.

Spice handling operations are subject to environmental facility controls, environmental sampling and test, process validation, Good Agricultural Practices (GAP), current Good Manufacturing Practices (cGPM), sanitary transportation rules, as well as packaging, labelling and other controls.

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Virtually all processed foods use spices to enhance flavors. Most spices used in the United States are imported, often from unknown, unregistered and unregulated farms prior to moving to larger handling and packing centres in the U.S. Most spices are grown and imported from tropical environments and are hand harvested with little or no food safety controls.

Knowing where and how spices are harvested and handled and the basics of spice food safety will prepare your company to prevent outbreaks that can destroy your company.

If your company is involved with spices in any way, you need to assure that you have appropriate food safety controls in place. With new reports becoming public, it is obvious that in spite of being classified “generally regarded as safe” (GRAS), spices are not as safe as previously thought.

This session will cover outbreaks as well as basic microbial reduction techniques, drying, testing, preventive controls, sanitation operation procedures, water issues, pest controls, storage, facility controls (air/dust/humidity), and other basic spice handling food safety considerations.

  • All Registered food Facilities involved with spices and Dried Herbs
  • Domestic Spice Receivers and Foreign spice Suppliers to U.S. markets
  • Spice Growers, Packers, handlers, Transporters
  • Processing, Carrier and Distributor Facility owners and Managers
  • Spice importers, Handlers, growers, and Packers
  • Food Safety and Quality Personnel whose operations are involved with spices
  • Process and facility sanitation and maintenance personnel
  • Spice purchasing and supplier qualification personnel
  • Company Compliance Officers
  • Internal and External Auditors
  • All Restaurant and Food retail store Owners and Managers

The Best Explanation of Lean Document you ever Heard

Will show the immense benefits of lean documentation practices for the life sciences industry.

Manufacturing processes have to function in tandem to produce a product. In the same manner, a sound, well-coordinated business process leads to the establishment of controlled documents. Extending the analogy further, if in manufacturing, lack of components can become an impediment for finishing a product; lack of information or its diversion into other documents becomes the logjam for a document. Most life science companies realize the role and value of lean manufacturing, lean laboratory, and lean operations, but are usually lax when it comes to maintaining controlled documents and systems.

This is not to devalue the importance of these other lean practices, but most companies in this sector seem to overlook the importance of putting a lean document practice in place, little realizing that this is of inestimable importance in cutting down operating expenses. Most life sciences companies, even well-established ones, seldom realize that the absence of lean documentation hampers the introduction of process improvements in a timely and effective manner.

Understanding of how to adapt lean documentation practices for the life sciences field

This webinar is all about how lean documentation can add enormous value to your organization. In what is sure to be the best explanation of lean documents you can hear, Angela will explain the importance of lean documentation threadbare and show how to implement lean documents and lean document control that both cut costs and ensures compliance with regulatory authority requirements.

Angela, who brings an astounding four decades of experience in the Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds areas, will show the immense benefits of lean documentation practices for the life sciences industry.

At this webinar, she will cover the following areas:

  • Definition of lean documents
  • What’s wrong with traditional document approach
  • Theory of Constraints and Lean Manufacturing
  • Applying lean manufacturing principles to Document Control
  • Applying Theory of Constraints
  • Examples of various types of lean documents
    • Design History File
    • Device Master Record
    • Device History Record
  • Typical challenges and how to overcome them
  • Preparing for an electronic document system

This session will be of value to Design Engineers, Manufacturing Engineers, Operations Managers, Document Control Managers, Lean Project Managers, IT staff that implements Electronic Quality Control, and those in Purchasing, Quality Assurance and Document Systems.

Four Trendy Ways to Improve on Microsoft Outlook tips

They will simply open their inbox, do what is required, and be done with quickly.

“Microsoft Outlook Tips, Tricks, and Productivity Tools” is the topic of a one-hour webinar that is being organized on February 5 by Compliance4All, a leading provider of professional training for all the regulatory compliance. Tom Fragale, a Microsoft Certified Trainer and a Microsoft Certified Expert in Excel, will be the speaker at this webinar.    http://bit.ly/2RIeovD

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Microsoft Outlook, the web-based webmail, contacts, tasks, and calendaring services suite, offers many benefits for office staff with its tasks, follow-ups, contacts, notes and calendar features. Yet, let us face it: its users find it ponderous and often confusing and difficult to use, despite the series of changes that Microsoft has brought into it over the years.

How does one overcome this issue? By attending this webinar. Here, Tom Fragale, who during his over 30 years of professional tenure has trained over 30,000 business people in on-line webinars, public seminars, and on-site training, will show four trendy ways to improve on Microsoft Outlook tips.

At the end of this webinar, participants will have learnt how to use Microsoft Outlook more confidently and to efficiently organize their information and commitments. Tom will show participants a series of smarter tips, tricks and systems with which they can manage their tasks, follow-ups, contacts, notes and calendar items better. Far from being a textbook handout, this session will be a thoroughly enjoyable one with lively talk and a lot of interactivity.

Participants will no longer find themselves having to sift through a stuffed inbox or having to respond to meeting requests all day. They will simply open their inbox, do what is required, and be done with quickly.

Immense uses from learning MS Outlook best practices

The MS Outlook best practices that Tom will impart at this webinar will make working on this program a lot less boring and time-consuming. He will how to optimize the uses of this versatile program, which can be immensely helpful to those who want to put it to the best use.

Tom will cover all the aspects of MS Outlook at this session. He will cover the following areas:

  • How to create and use an Outlook “To-do” list
  • How to easily build your contacts list
  • How to keep your notes and ideas in email folders
  • Tricks for automating your emails
  • Calendar tricks that save you time
  • Creating and using Folders to help you organize better
  • Creating Rules to automatically handle emails
  • Flagging Emails for Follow
  • Sorting and Filtering Emails
  • Mail Merge with your Contacts.

This webinar is of high value to those who use MS Outlook day in and day out, and these include:

  • Business Owners
  • CEO’s/CFO’s/CTO’s
  • Managers of all levels
  • Anybody who uses Excel on a regular basis, and want to be more efficient and productive
  • Administrators
  • Salespeople
  • Trainers
  • Bankers
  • Office Workers.

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About the speaker:

Tom Fragale’s clients include many Fortune 500 companies, government agencies, military bases, and companies large and small across many industries, including manufacturing, banking, pharmaceutical, education, retail, etc. He is an expert at Access, Excel, Word, PowerPoint, Outlook, Crystal Reports, SQL Server, Visio, QuickBooks, and SharePoint, among others, and has even written a book on Microsoft Access.

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