Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA's recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

o   Very Early Stages

o   GLP requirements

o   Early Pre-IND Studies

o   Meetings and Preparing for the IND

o   GMPs for Phase 1 IND products

o   Requirements for Phase 2 INDs

o   Preparing for IND Meetings 

Medical products need to be validated for Radiation Sterilization

“Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions.

To get this right, one simple line of thinking is crucial for medical device manufacturers to inculcate: To “think like a molecule”. This is the basis on which to plan and design around radiation induced changes in the qualities such as color, odor and brittleness that go into the materials.

Learning the right method

Professionals in the medical devices industry, who work on these aspects will benefit immensely from a two-day seminar on the topic, “Validating Radiation Sterilization for Medical Products”, which is being organized by GlobalCompliancePanel, a highly popular provider of professional trainings for all areas of regulatory compliance.

The Director of this seminar, Karl J. Hemmerich, President of Ageless Processing Technologies, who brings over 35 years of experience in medical device product design, development, manufacturing, and sterilization, will offer a range of learning on this topic.

Identifying the best suited materials

Apart from helping participants identifying the materials that perform best upon radiation, keeping color and odor out of their irradiated products and enhancing product and packaging designs to take advantage of radiation; he will also offer understanding to them on how to avoid the materials that are certain to fail.

This seminar, for which medical device professionals can enroll by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900685SEMINAR?validating-radiation-Washington-DC, has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Understanding optimum sterilization modality

Participants will also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics and understand which modality (Gamma, E-beam, or X-ray) will perform best for their product.

Karl will cover the areas relating to validation of radiation sterilization for medical products, such as Materials Guidances - AAMI TIR # 17, ASTM, sterilization validation and bioburden, Shelf Life Test Methods - Accelerated Aging design, Test 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, and biological polymers - tissue, serum at this two-day in person seminar.

The following areas will be covered at this seminar:

o   Polymers Chemistry - choosing the best polymer candidate

o   Gamma, E-beam, X-ray sterilization

o   Accelerated Aging

o   Product Qualification

o   Sterilization Validation - Establishing the Minimum Sterilization dose (VDmax)

o   Sterilization Modality Selection Criteria

o   Biocompatibility

o   Preventing Plastic Part Failure Post Irradiation

Ensuring compliance with healthcare laws is of utmost importance for healthcare providers

Compliance with the many laws, as well as implementation of the necessary compliance initiatives are the means by which healthcare providers and entities or organizations involved in any type of healthcare transaction, especially those who bill or are involved with services payable by a CMS program, play a part in the protection of the integrity of  the CMS programs.

Developing and maintaining the necessary compliance programs that place a special emphasis on auditing and monitoring, appropriate training, receiving and responding to complaints and conducting investigations is necessary for providers, entities and organizations that bill Medicare, Medicaid or other government payor programs. Those whose compliance program fails to incorporate the necessary control processes risk inviting potential audits that could lead to civil, monetary and criminal penalties.

Understanding risks is necessary for healthcare practices

The ways by which to understand potential risks relating to their practice or organization and responding and mitigating deficiencies are all-important for healthcare organizations if they have to sustain their success and viability. This is also necessary if the organization has to avoid or neutralize the impact of negative findings by an external audit or investigative agency.

Moreover, with the many impactful changes taking place in the healthcare delivery; healthcare provider reimbursement could be affected. Quality of care and reduced costs will bring about changes into provider reimbursement for services. Healthcare providers have to understand how these changes are going to affect them.

Learning ways of implementing compliant programs

A two-day in person seminar by GlobalCompliancePanel, a highly reputable provider of professional trainings for all areas of regulatory compliance, will offer understanding on all these areas of healthcare compliance. This course, at which Gail Madison-Brown, a Registered Nurse and attorney who has spent over 25 years in the healthcare industry, and is Chief Clinical Trials Officer at UTHSCSA will be the Director,  will focus on ways by which healthcare organizations can devise means by which to stay compliant with the regulatory guidelines and laws.

To enroll for this seminar and to get a thorough understanding of how to implement practices that are compliant with regulatory requirements, just visit 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900544SEMINAR?ensure-healthcare-compliance-Seattle-WA.

Ways of building a robust and pragmatic compliance program

Attending this seminar will help participants understand how to build a solid and practical compliance program. Gail will introduce the basic healthcare compliance infrastructure necessary to establish a comprehensive and proactive compliance program. She will then discuss current government auditing agencies and audits that are underway, as well as government agencies responsible for protecting the Medicare Trust Fund from fraud, waste and abuse.

She will teach participants the ways of identifying risks in their organizations, no matter what their size, by conducting a risk assessment and developing a work plan based upon risk and will help with the mitigation efforts. Apart from OCR audits and how to conduct their own self-assessment in preparation for an audit, as well as ways of addressing any identified deficiencies; participants will also learn how to conduct auditing and monitoring activities and what to do with findings. Ways of putting in place a complaint management system and conducting an investigation will also be discussed. The Director will also offer user friendly templates and tools, as well as numerous case scenarios to the participants, which they can use to enhance current compliance programs.