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

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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.

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.

GMP Environmental Control for Pharmaceutical Clean Rooms

The subject of clean room contamination due to personnel is discussed.

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

This webinar first details and explains the various US and international regulatory requirements for various clean room classifications. Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

The principles of HEPA filtration are described along with desired clean room airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

Comprehensive procedures for cleaning and sanitization of the clean room environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages. The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.

Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the clean room environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Personnel Gowning and Aseptic Practices in Clean Room

Risk Based Incident Management and CAPA for GxP Computerized Systems Operations

Recognizing that the control of the resolution and implementation of the correction may be managed by other processes.

This specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

An incident is any unplanned occurrence which prevents (or may prevent) or delays users, the system, an operation, or a service from proceeding with an assigned task. The Incident Management process is intended to provide effective support for unexpected events to users of laboratory, process control, and IT systems.

The CAPA process captures those incidents and failures escalated from the incident management and periodic review processes. These are then tracked from initial occurrence, through impact assessment to resolution and implementation of the correction, recognizing that the control of the resolution and implementation of the correction may be managed by other processes.

The CAPA process also accommodates the situation in which a failure needs both corrective action (to fix a failure) and additional preventive action (to avoid the failure occurring again).

corrective action capa

Whenever possible, processes discussed will be aligned on the Quality Management System described by ICH Q10 (Pharmaceutical Quality System) and ICH Q9 (Quality Risk Management).

 

  • How the Operations Phase fits into the Quality Management System
  • Operations Phase Processes Lifecycle
    • Capture of Operational Control Requirements
    • Design of Operational Processes
    • Verification of Processes
    • Deployment of Processes
    • Verification of the Effectiveness of Processes
    • Process Relationships
  • Risk Management for Operational Processes

 

  • Managers/Directors/Supervisors and Personnel related to:
    • IT
    • Validation
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
  • Complaint Handling
  • Personnel New to the Regulated Industry
  • Training Personnel
  • Document Control Personnel
  • Regulatory Personnel

Risk Management for Operational Processes http://bit.ly/2UmYyIt

 

 

 

How to plan for post radiation resistance and lifetime functionality

Will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

  • Materials Guidances – AAMI TIR # 17, ASTM
  • Sterilization validation and Bioburden
  • Shelf Life Test Methods – Accelerated Aging design
  • Product design
  • The influences of product assembly (molding, automation, etc.)’
  • Material selection and post irradiation degradation
  • Regulatory Guidances – AAMI/ISO 11137, TIR #17
  • Packaging Design and Materials

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“Do it right the first time”, choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics. Learn how to “think like a molecule” and plan and design around radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are “APT” to fail.

Learn how to:

  • Keep color and odor out of your irradiated products
  • Enhance product and packaging designs to take advantage of radiation
  • Medical Product Design Engineers
  • Sterilization Experts
  • Quality Management and Engineers
  • Regulatory Affairs
  • Project Managers
  • Purchasing and Supply Chain Managers
  • Staff Evaluating Risk, Safety, and Effectiveness
  • R&D Staff – Engineering and Lab Personnel
  • Process Engineers
  • Packaging Engineers
  • Materials Engineers
  • Manufacturing Engineers

Identify the materials that perform best upon radiation

Design Verification and CAPA Effectiveness Checks [Plans for Process] Validation

How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates.

This is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • How to link risk with the confidence statements associated with the sampling plans
  • Identify a variety of sampling plans, that all make the desired confidence statements
  • Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
  • How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates

Approaches and sources of such plans are explained and contrasted with manufacturing sampling plans.
Ensure compliance when selecting sample sizes.
Learn strategies for reducing sample sizes.
Learn strategies for avoiding false rejections.

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  • Claims that can be made when passing a sampling plan
  • How to select a sampling plan to make a specific claim
  • Different types of sampling plans including single, double and variables
  • How to reduce the number of units tested
  • How to increase the chances of a good product/process passing a validation
  • How to write protocols to handle contingencies so to avoid deviations
  • Practical considerations including selecting representative samples

Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics including Robust Design, Tolerance Analysis, Design of Experiments, Trending and Acceptance Sampling.