This 510(k) webinar will help you understand the proposed changes to 510(k) process in 2011 and the regulatory process of implementing it. This 520(k) webinar will address both sides of the proposed changes. We will discuss how the expected change will affect device makers in terms of additional cost, affect on number of devices cleared, what is the regulatory process for implementing the changes. We will also discuss what industry has to prepare for the statutory changes coming in 2011.

This Medical device inspection webinar training will teach you A to Z of inspection starting with how to prepare to what to do during inspection, close-out interview, FDA’s scope, what documents to show and how to respond to the inspection. Areas Covered in the Seminar: How to prepare for an FDA inspection. Development and contents of an SOP for FDA inspection. Personnel training before inspection. How to behave during an inspection. Limitations of scope of inspection. Response to investigation findings. FDA guidance documents used by their inspectors. Who Will Benefit: This webinar will provide valuable assistance to all companies that…

"Chemical Dependency and the Family" will be presented on Tuesday January 25, 2011, from 7:30 pm to 9:00 pm; by Nancy J. Quay, LMSW; psychotherapist. This program will provide participants with a basic understanding of how addiction impacts each member of a family. The presenter will describe the roles and behaviors that family members often acquire when living with addiction, ways in which each family member is affected by addiction in the family, and options for family members to obtain help to cope with addiction in the family. This program is part of the FREE, annual Dawn Farm Education Series.…

Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization. Areas Covered in the Session: * Understand the basic water system…

Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. Reference material for easy implementation: * 25 recent FDA Warning Letters with part 11 violations. * 15 Case Studies: Implementing Part…

This OSHA Recordkeeping training will address the key concepts in understanding the OSHA recordkeeping analysis. This training will include hypothetical fact scenarios that present common recordkeeping issues encountered by facility record keepers. OSHA injury and illness recordkeeping compliance is a point of emphasis for OSHA, and the recordkeeping regulations are frequently cited by the Agency. This 2hrs and 30 minutes OSHA Recordkeeping webinar training will address those key concepts that must be understood for accurate OSHA recordkeeping. The presenter has audited hundreds of employers’ OSHA 300 Log recordkeeping practices, has defended OSHA recordkeeping citations, and is a frequent speaker on…

Interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA Friday, January 21, 2011, 9:00 AM Pacific to 5 PM Pacific ComplianceOnline partnered with nationally renowed law firm DuVal & Associates to bring this workshop containing 6 hrs training plus 1.5 hr Q & A program and featuring nationally known regulatory attorneys Mark DuVal and Mark Gardner, who have worked on hundreds of 510(k)s, de novo submissions, PMAs and combination products. They will offer insights on the 510(k) process from submission writing and FDA meetings to commercialization strategies for your device. Conference Details:- Price…

Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas Covered in the Session: * Preventive Maintenance…

Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies…

This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. This webinar provides the information about contents of the records and lessons for implementation. Learning objectives: State the four major records required in FDA’s QSR. Describe the contents of the Design History File (DHF). Explain the source of the Device Master Record (DMR). Describe how the Device History Record (DHR) relates to the DMR. State the required content of…

Understanding of IRB application components and how to find out and fix problem areas before it threaten your trial to fail. Submitting an IRB application right the first time requires a lot of attention to detail. Once a successful application is approved, it is important to keep up with the continuing requirements/submissions/changes etc. Attend this webinar to learn what the IRB is looking for and how to expose and fix problem before they threaten you trial and learn about the role and responsibilities of an efficient well rounded CRC. Areas Covered in the Seminar: IRB- Purpose, Use, Responsibilities. IRB Application…

Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure would be reasonably…

Overview: In this presentation, we will review recent medical device manufacturers Warning Letters to determine the inadequacies of responses by manufacturers. After finding the weaknesses in the responses, we will identify those characteristics of an adequate response by manufacturers to avoid a Warning Letter and additional enforcement actions by FDA. All medical device companies preparing for FDA inspections should review the information in this presentation and prepare a plan for response to an FDA-483 before the FDA arrives. There will be insufficient time to react during an inspection and after an FDA investigator leaves a FDA Form 483 to develop…

International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, announced today that its Chairman, Kenneth Aldrich and the CEO of its Lifeline Skin Care subsidiary, Ruslan Semechkin, PhD, will present a Webinar discussion of the State of the Company and its plans for its Skin Care subsidiary on Wednesday, January 19, 2011 at 10:00 a.m. PST. In announcing the event, Mr. Aldrich stressed that its purpose is not to announce any new programs or financial results, but to attempt to provide an overview of events during the past year and offer shareholders a perspective on what to expect in the coming year. The…

This change control training will discuss the best practices to create a FDA compliant system. Areas Covered in the Seminar: QSR requirements for document change control. Description of typical document change control system in use. Streamlined document change control process. Paper-free document review. Immediate document distribution. Paper-free document management system. Document change requests: submission, processing, and review. Document change approval and distribution. How to handle "Minor" changes. Streamlined document change control process. Change control for design documentation. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on change control.…

"Trauma and Chemical Use and Addiction" will be presented on Tuesday January 18, 2011, from 7:30 pm to 9:00 pm; by Dr. Tana Bridge, Ph.D., LMSW; MSW Program Director, School of Social Work, Eastern Michigan University. Current research highlights the relationship between chemical use, addition and trauma. This presentation by an award-winning trauma expert will review events involved with trauma exposure, trauma specific symptomology, the impact trauma has on the brain and on coping and subsequent substance use, and how to aid individuals struggling with trauma and addiction. This program is part of the FREE, annual Dawn Farm Education Series.…

Overview: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their sample size. Most auditing sampling plans are based on either the binomial or normal distribution, though rare events usually follow the Poisson distribution. This talk will show how the Poisson relates…

Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled. It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. Most importantly, when do…

Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques.…

This environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs. Areas Covered in the Seminar: Best practices for monitoring and establishing limits. Product bioburden Viable particulate Non-viable particulate Do I really need to investigate if the alert limits are exceeded? Investigating an alert limit excursion. In the environment On the product Who to investigate. What to investigate. When - what is the appropriate…