eCTD Submissions of IND/NDA to the US FDA, EU and Canada

It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Those who are benefited by this

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.

To compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

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GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Analytical and laboratory certification
  • Documentation and maintenance of records
  • Consequences of noncompliance
  • Disqualification and reinstatement

Who will be benefited by this

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development Personnel
  • Regulatory Affairs Personnel
  • Project Managers
  • Manufacturing Managers
  • Validation Engineers
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Auditors

Instructor Joy McElroy With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Upcoming Changes with HIPAA 2019

The entire HIPAA Security Rule and uncover simple methods to comply and create policy.

The entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Do you know all of the requirements of this enigmatic law? Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task Times have changed and new laws are now in place concerning protected health information.

The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive This once rarely enforced law has changed and you need to know what’s going on! Protect your practice or business!

These day’s trial attorney’s pose an even higher risk than the Federal government!

State laws are now in place increasing liability for patient remedies!

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will be discussing 2019 changes taking place in Washington with the Health and Human Services regarding the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the audit process and some current events regarding HIPAA cases (both in courtrooms and from live audits)

Instructor cover all these areas:

  • Study all 18 Standards and 44 Implementation Specifications of the regulations
  • Updates for 2019
  • Requirements of Compliance Officers
  • New definition of what constitutes protected health information
  • Real life litigated cases
  • BYOD
  • Portable devices
  • Business associates and the increased burden
  • Emailing of PHI
  • Texting of PHI
  • Federal Audit Process
  • HIPAA and suing – how this works
  • Risk Assessment
  • Best resources

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention period.  The data is a key asset for any FDA-regulated company and must be protected.  If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated.  This could result in a devastating loss to any company’s bottom line.

We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only.  In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing.  The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance and FDA enforcement.  Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.  Others are based on factors including economics, social media, new diseases, politics, and a host of other influences.

Instructor:

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

  • Information Technology Analysts
  • Information Technology Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists

Here to go in details

A guide to practical Risk Management – Applying ISO14971 and IEC62304

It will help to comply with regulatory requirements with minimized overhead and resource burden.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

Want To Step Up Your HIPAA? You Need To Read This First

You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.

Confused about all of the misinformation relating to HIPAA, what you can and can’t do?

Join me in the six-hour virtual seminar and let me get those questions FINALLY answered for you once and for all!

There is unfortunately a lot of confusion about transmissions of protected health information and what we as business associates and covered entities need to do and what we SHOULD NOT do!

Join me in this six-hour virtual seminar as we discuss the do’s and don’ts regarding texting and emailing along with any other sorts of transmissions of protected health information!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, emailing, and transmission in general of protected health information (PHI).

You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.

I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk.
These day’s trial attorney’s pose a higher risk than the Federal government!

I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

I will speak on specific experiences from over 18 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.

More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
Don’t always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required.

Best Biostatistics Tips You Will Read This Year

How do you know if you are pressing the right key, let alone performing the best test?

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?

biostatistics

This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.

Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.

  • Physicians
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Sponsors
  • Regulatory Professionals who use statistical concepts/terminology in reporting
  • Medical Writers who need to interpret statistical reports