3-Hour Virtual Seminar on FDA’s section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

Have you noticed that in relation to the prices of most prescription drug products in the rest of the world, those in the US are sky-high? This has serious implications for patients, physicians, and the US healthcare industry itself. It raises doubts about the kind of competition that exists in the US markets for these drugs.

 

Consumers of these expensive prescription drugs in the US could experience a potential relief when a new policy approach, such as importation under section 804, is implemented. This might effectively limit prices and protect consumers from unreasonable price increases.

What is the FDA’s position on this issue? It has determined that a narrow implementation of section 804 through time-limited programs, overseen by States or certain other government entities (with possible co-sponsorship by a wholesaler or pharmacist), could enable importation to happen, provided the certification criteria it sets forth are met.

Obviously, implementing this rule could potentially provide relief to some American consumers who are forced to opt for prescription drugs that are exorbitantly priced. The HHS and the FDA propose to implement this through two proposed pathways-Section 804 Drug and 801(d)(1)(B) Biologic Importation Programs-through which certain drugs originally intended for non-US markets will be allowed to be imported.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain the dynamics of the two pathways that the FDA and the HHS propose for allowing importation of creating drugs originally intended for non-US markets- Section 804 Drug and 801(d)(1)(B) Biologic Importation Programs and the pathways they propose.

Angela Bazigos, the CEO of Touchstone Technologies Inc., will be the expert at this webinar, which is being organized on April 21. Please enroll for this valuable learning by visiting Compliance4all

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At this webinar, Angela will explain the Section 804 Drug and 801(d)(1)(B) Biologic Importation Programs. It is interesting to note that both these pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

Angela will explain these pathways by covering a range of areas that come under them:

Section 804 – Pathway 1

  • Definition of Section 804 Importation Program (SIP)
  • Who would be permitted to sponsor a SIP
  • SIP authorization duration
  • Entities other than a sponsor and co-sponsors (if any) that would be involved in the SIP supply chain
  • Could a SIP Proposal include multiple foreign sellers and importers?
  • Statutory basis for FDA’s SIP proposed rule
  • Proposed criteria for a drug to qualify for importation from Canada under a SIP
  • Categories of drugs proposed to be excluded from importation under a SIP
  • SIP sponsors requirements
  • Information required for SIP Proposal
  • Testing requirements for SIP drugs
  • Eligibility criteria for SIP proposal
  • Importation process following FDA approval of SIP proposal
  • Entry submission options
  • Manufacturers:
    • Definition
    • Role in the SIP process
    • Manufacturer requirements
  • Foreign Sellers
    • Definition
    • Role in the SIP process
    • Foreign seller requirements
  • Importers
    • Definition
    • Role in the SIP process
    • Importer requirements
  • Labelling requirements for drugs under SIP program
  • Application of FDA’s National Drug Code (NDC)
  • Cost savings for SIP drugs
  • Post importation requirements
  • Federal Health Care coverage and US Drug Price Reporting
  • Supply Chain Security
    • Pre-US supply chain information from manufacturer to importer
    • Supply chain security requirements for foreign sellers
    • Track and trace information from the foreign seller to the importer
    • Purchasing product from a foreign seller if they are not an “authorized trading partner”
    • Information to be confirmed by importer when receiving product from a foreign seller
    • Track and trace information from the foreign seller, as required by the DSCSA
    • SNI portion of the product identifier: can the importer use the same serial number (i.e., the SSI) as the foreign seller
    • Where can importers ship eligible drugs to
    • What other DSCSA obligations would apply to importers
    • Information importer obtains from a manufacturer regarding a product’s pre-US supply chain

Section 801(d)(1)(B) – Pathway 2

  • Purpose of Pathway 2
  • Importing drugs under Pathway 2 vs Pathway 1
  • Countries acceptable for Pathway 2
  • Multi-Market Approved (MMA) products
  • Pathway 2 requirements
  • Labelling requirements for MMAs
  • Supplemental approval requirements for MMAs
  • Registration and listing requirements for MMAs
  • NDCs for Pathway 2
  • Supply Chain Security
  • Pricing requirements
  • National Drug Code (NDC) requirements

About the speaker: With degrees in Microbiology and Computing, Angela has some forty years of experience in the life sciences, healthcare & public health services areas.

She has co-authored and prototyped 21 CFR 11 guidance with FDA and has co-authored Computerized Systems in Clinical Research with FDA & DIA Patent on speeding up software compliance. She was recently quoted in the Wall Street Journal for using training to bring regulatory compliance to the boardroom, which includes training for the Society of Quality Assurance, and has appeared in Stanford’s Who’s Who for Life Sciences.

 

The 7 Habits of Highly Effective Project Managers

Have you noticed that more often than not, it is due to their proven technical skills and competence that Project Leaders and Managers are chosen for their roles? The reasoning is that anyone who is good at the technical level is necessarily good at the project management area as well.

But does this have to be true? Not really. It is never a proven fact or a given that technical competence and project management are synonymous with each other and have to necessarily accompany one another. Demonstrated technical proficiency is never a prerequisite for project management skills, which essentially call for planning well to accomplish a project within the deadline and with the given budget.

In this sense, project management is more a soft skill than a purely technical one.  For organizations to manage and complete their projects within the given deadline, their Project Leaders and Managers need to get trained on the various aspects of project management, which, when supplemented with technical skills, can fetch the desired deliveries and results.

How do technically sound professionals learn the core aspects of project management? A webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on March 25. will show how. At this webinar, Steve Gompertz, President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality, will be the expert.

Please log on to Compliance4all  to enroll for this highly valuable session.

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This webinar is the ideal learning for Project Leaders, Project Managers, Program Managers, and those in Project Management Office, who constantly face issues such as these:

  • Their projects often feel more like a task list than an integrated workflow
  • They often feel like their project schedule has been hijacked by task owners
  • Their project status, instead of being measured, is being monitored
  • They are unaware of the one thing to get right that would guarantee project success
  • They are assuring quality in their project’s deliverables or assessing it after their completion
  • They feel that Management doesn’t understand what they trying to tell them about project status
  • They could be treating project management less as a profession and more as a hobby.

At this webinar, the expert will use the late Stephen Covey’s framework for “The 7 Habits of Highly Effective People®”, to instill into the participants a better way of understanding important behaviors, tips, and tricks that will ensure project success.

He will cover these areas at this session:

  • Treating the project plan as a system rather than a to-do-list
  • Maintaining control of your project’s “float” to effectively manage schedule variance
  • Quantitative methods for measuring and communicating project status
  • Focusing on the one thing that must be done before everything else to ensure project success
  • Integrating quality management with project management
  • Learning how to talk to Management about project status and have them actually understand it
  • Taking project management seriously as a full-time role rather than just being something else to take care of.

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About the expert: During the more than 25 years that he has been in the life sciences industry, Steve has worked for reputable companies in areas that include Quality Systems development and implementation, project management, engineering automation, configuration management, audit, and software development.

A leader in Quality Systems management, Steve is also an Adjunct Instructor in St. Cloud State University’s Master of Science in Medical Technology Quality program, which he helped develop.

Quality Management, biomedical auditing, Regulatory Affairs, project management, and configuration management are some of the areas in which he specializes and is certified.

 

Quality by Design: Design Controls for Medical Device Companies

The paramountcy of Design Controls to Medical Devices in ensuring product quality can be assessed from the fact that the FDA considers it so. Apart from what the FDA thinks or says, Design Controls are critical to ensuring the quality, safety and effectiveness of a medical device at all the stages of its manufacture.

Design Controls are integrated management practices that are aimed at ensuring the quality and consistency of a medical product. They are customer focused, and are carried out rigorously and methodically. The intended benefit that Design Controls bring is the prevention of the many undesirables, the most crucial of which is a dent in customer confidence.

Apart from being a regulatory requirement, Design Control is a set of aligned practices that deliver a predictable design process resulting in better product development and the development of more successful products. Lack of the right Design Controls and risk management is a prescription for product design problems, an erratic product development process, and reduced customer satisfaction for medical device companies.

Not getting Design Controls right also has the potential for attracting penal actions from the FDA. The agency could issue 483s or Warning Letters, or order even recalls.

A ninety minute learning session from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 30, will show all the ways of preparing the right Design Controls for medical devices into which risk management is built. Accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, Susanne Manz, will be the expert at this webinar.

Please visit  Compliance4all   to register for this learning.

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At this webinar, Susanne will show how to create a Design Control process that is effective, efficient, and compliant. It will help the participants use Design Controls efficiently with the aim of designing and launching new products that meet quality objectives and business needs in an efficient and predictable manner.

Participants of this webinar will be able to understand regulations and expectations, review enforcement case studies for lessons learned, understand the Design Control Process, understand its link with Risk Management, identify Best Practices, and prepare a plan for inspection readiness.

The expert will cover the following areas at this webinar:

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Design Control Process
  • Planning
  • Design Inputs
  • Design Outputs
  • Verification
  • Validation
  • Design Review
  • Design Transfer
  • Design Changes
  • Design History File
  • Linkages to other Quality System Requirements
  • Lessons Learned and Enforcement Case Studies
  • Best Practices
  • Preparing for an FDA or NB Inspection

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

 

FDA Best Audit Behavior Practices – Do’s and Don’ts

Any regulated business, such as pharmaceuticals or medical devices, is expected to face an inspection by the FDA. The Food, Drug and Cosmetic Act mandates that a registered domestic drug establishment should be inspected by the FDA at least once in two years. These inspections could occur more frequently, depending upon the inspection type and the circumstance.

Regardless of how right a business thinks it is with its practices, it should be prepared for consequences that arise from an FDA inspection. The way its employees behave with the FDA inspectors can have an impact on the results reported. The method of Interacting with inspectors is an effective technique that must be learned and mastered for the inspections to carry positive outcomes.

A sixty-minute webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show exactly what needs to be done during an FDA inspection to beget the best results from it.

For this valuable training, Compliance4All brings the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, as the expert. Please visit Compliance4all to register and gain valuable insights into this crucial learning.

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Charles will begin this session by giving an understanding of and emphasizing the importance of truthfulness. He will underscore the importance of truthfulness from the standpoints of performing the job on a daily basis, truthfulness in completing the regulatory documentation that is such a core part of our careers in the regulatory industry, and finally, truthfulness when interacting with the FDA inspectors.

He will next impart an understanding of another key component of this webinar, which is the types of tricks and techniques that inspectors use to elicit information. The way in which employees react and respond to these techniques has an impact on the results.

He will then move on to the communications skills needed in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

The expert will round up the session by showing the ways of handling adverse findings when FDA inspectors find them, in a manner that does not go on to exacerbate the issues and severity of the findings.

Charles will cover the following areas at this webinar:

  • Importance of truthfulness
  • Importance of knowledgeability and confidence
  • FDA Tricks to elicit information
  • Arguing and challenging
  • Behavior during the inspection
  • Importance and role of documentation
  • Effective communication skills
  • Being deceptive
  • Opinion versus fact
  • Phrases never to say
  • Handling adverse findings during the inspection

Those in positions of management and supervision, such as Vice Presidents, Directors, Associate Directors, Managers and Supervisors in all functions, those in compliance and regulatory roles who spearhead the inspections and are responsible for compliance readiness, will find this course useful.

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About the expert: Paul’s company, C. H. Paul Consulting, Inc., is a regulatory, manufacturing, training, and technical documentation consulting firm. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years, and has published numerous white papers on various regulatory and training subjects.

Apart from holding senior positions in consulting and in corporate training development, he has also worked for several years in government contracting, where he has managed the development of significant Army-wide training development contracts. His work has impacted virtually all of the active Army and changed the training paradigm throughout the military.

European Union Device Regulation (EU MDR)

The new European Union Device Regulation (EU MDR), which will become effective in May 2020, introduces the most far-reaching changes into the medical device industry in the European Union (EU) till now. Replacing the earlier MDD, the EU MDR drastically expands the requirements for conformance.

 

It is a massive document that is spread over 174 pages, nearly three times the size of the MDD. It is replete with 123 Articles in 10 Chapters and 17 Annexes. Despite its already heavy size, it is still incorporating new requirements and expanding existing ones. Its fast approaching deadline is leaving medical device manufacturers limited time to prepare.

It goes without saying that products destined for import into the EU must comply with these new regulations. Among the prime requirements that a medical device company has to undertake is an arrangement to be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance. All of these call for extensive preparation.

Not doing this rightly has its consequences. A valuable webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain what needs to be done to meet the deadline, so that the unpleasant consequences of noncompliance can be avoided.

For this webinar, Compliance4All brings Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past eight years, as the expert.

Please log on to  Compliance4all  to register for this very important learning.

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The core objective of this webinar is to explain and clarify these new and expanded requirements. In the course of doing this, Edwin will cover these areas of all the aspects of the new MDR at this session:

  • EU MDR objectives
  • QMS requirements
  • Device classification changes
  • Documentation requirements
  • Clinical evaluation requirements
  • UDI and labelling requirements
  • Post market surveillance
  • New Notified Body obligations
  • Human Factors/Usability requirements

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About the speaker: A Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network; Edwin Waldbusser is a consultant who has retired from industry after 20 years in management of development of medical devices. He holds five patents.

 

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

As suppliers and contractors work closely with pharmaceutical or biologic finished product manufacturers for a variety of tasks and processes, it is natural that many misunderstandings could happen between them.

The fundamental reason for which this happens is that the parties fail to come to a properly documented and suitable agreement in which the roles and responsibilities are delineated, and the responsibilities that each has in relation to resolution of disagreement of these issues are clarified. Developing, supporting and updating of confidential technical files (Drug Master files) lie at the core of these arrangements.

Doing these activities right helps the suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency. So, what are the ways by which to do this?

This is the learning a webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 31, will impart. Robert J. Russell, a senior global regulatory and CMC expert, will be the expert at this ninety-minute webinar. Please log on to  Compliance4all  to register for this valuable learning.

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The core of this session, which combines learning of Quality Agreement and DMF (Drug Master Files), is to discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This session is aimed at the benefit of those in manufacturing, Regulatory Affairs, project management, global supply chain, Research and Development, Quality Assurance and Quality Control, validation, development and preparation of submission materials, and general management.

Over the course of this session, Bob will cover these areas:

  • What are DMFs?
    • Types of DMFs (Types II, III, IV and V)
  • The rationale and preparation process for DMFs
    • Why DMFs are important to you and your company
    • How DMFs fit into FDA’s regulatory processes for review of drug and biologic applications
    • Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
    • What not to include
  • DMF Preparation: What you need and why you need it
    • The essential components of all DMFs, including:
    • The relationship between DMFs and cGMPs
    • Tactics for avoiding the most common DMF-related errors
    • Tactics for dealing with unique or novel situations/unfavorable reviews
  • FDA Review: How FDA reviews DMFs and why
    • What you should expect throughout the DMF preparation and filing process
    • How to communicate and work with FDA to ensure success
  • Components Associated with a DMF:
    • DMF vs. Application
    • Acknowledgement Letter
    • Letter of Authorization
    • Changes to a DMF
    • Annual updates
    • Obligations of a DMF holder
    • Transmissions – transmittal letter
    • Deficiency letter
    • Auditing Vendor
    • Inside tips
    • Changes to DMF system in last 10 years
    • Binder specifications and cover sample
  • Japan DMFs
  • European DMFs
  • Canadian DMFs
  • Change control and maintenance: Why accurately maintaining your DMFs is important
    • DMFs as “living” documents. DMF updates and amendments
    • Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
    • What you must report and to whom – the importance of establishing communication pathways with regulatory agencies, customers and vendors

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About the expert: Robert J. Russell is President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington DC, and Brussels, Belgium with exclusive affiliates across Asia and Latin America.
Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS/MS degree in Chemistry.

 

Controlled Document System for a Life Sciences Manufacturing Plant – Principles of Lean Documents and Lean Configuration

Maintaining their Quality Management System (QMS) processes in a state of control, by way of controlled documents and objective evidence, and documenting them in the form of records, is a core requirement for all life science businesses.

In addition, an additional responsibility that life science manufacturing plants have is giving the assurance that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions. They should also ensure that evidence of this work is maintained by controlled records.

 

In the pre-computer systems and databases era, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. Over the years, this system evolved into the extremely complex and convoluted systems that are prevalent today throughout the life sciences industry.

Although automation technology has brought in changes at this level, this has yet to completely replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.

The problem is that, all but only a handful of life science companies have outgrown the old manual habit. Their insistence on retaining legacy policy has been preventing them from reaping the full benefits of automation and information retrieval systems.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to approach document systems using the theory of Lean Documents and its upshot-the Theory of Lean Configuration.

José Mora, a senior professional in the medical devices industry, who is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, will be the expert at this session.

Please log on to   Compliance4all  to register for this session.

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This learning is for those who have been constantly struggling at creating, managing, and maintaining all of the information found in controlled documents. Apart from being redundant and repetitive, most of this is usually bunched together in a rather haphazard manner. By attending this webinar, participants will gain a different perspective and a very sensible approach that they can put to proper use and organize their controlled documents. The result is that there is no confusion or disorderliness in maintaining and presenting crucial documents. It will help them save on the enormous resources that unorganized maintenance of controlled documentation consumes. José Mora will present a new approach to documentation that is based on solid principles and proven practices.

This webinar will benefit Managers, Supervisors, Directors, and Vice-Presidents in the areas of R&D, Manufacturing Engineering, Design Assurance, Quality Assurance, Operations and Document Control.

José will cover the following areas at this webinar:

  • Brief introduction to Lean Documents and Lean Configuration
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
  • Basic functions found in a life sciences manufacturing plant
  • Key types of controlled documents and records for manufacturing
  • Quality Management System (QMS) elements controlled via documentation
  • Bringing it all together.

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About the speaker:

José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems, has worked in the medical device industry specializing in manufacturing, process development, tooling, and Quality Systems for over 30 years. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

He has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S’s (Visual Workplace), process validation to GHSS standards, and similar approaches in organizations in which he has worked.