Edt Web-based Seminars

Dental - Medical Cross Coding - Webinar By MentorHealth Medical Coding in dental practices is gradually becoming a necessity. Many dental practices have long been sheltered from having to explain to dental carriers why they performed the patients' procedures. They have simply submitted codes for the procedures that were performed. Wednesday, October 12, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Good Documentation Practices for GMP Operations - Webinar GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. Wednesday, July 11, 2012 10: 00 AM PDT |  more...

Regulatory Complaint Handling MDRs Recalls - Webinar GlobalCompliancePanel Overview: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Tuesday, July 3, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Statistical Procedures Needed for Compliance with the Guidance on Process Validation - Webinar By GlobalCompliancePanel Overview: This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft. Thursday, September 6, 2012  more...

GMP for Phase 1 Products - Webinar By GlobalCompliancePanel Overview: This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP. Tuesday, August 7, 2012 10: 00  more...

GxP Computer System Validation The investigators Point of View - Webinar By GlobalCompliancePanel Overview: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors. Tuesday, July 10, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

GMP Compliance for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: The U. S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. Wednesday, June 13, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

The FDA Inspection Process From SOP to 483 - Webinar GlobalCompliancePanel Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight,  more...

Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. Wednesday, June 27, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Management Controls Under QSR and ISO 13485 - Webinar By GlobalCompliancePanel Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Tuesday, June 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

First in Class First in Man Compounds Targeting Tumor Bioenergetics from Lab Bench to Clinical Trials Working with the FDA to me Overview: Many anticancer drugs are not tumor selective. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Preventing a therapeutic level to be achieved in a patient. Thursday, June 28, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing Drug Delivery and Dru Overview: Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Tuesday, June 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Current Companion Diagnostic Regulatory Framework in the EU US - Webinar By GlobalCompliancePanel Overview: This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

FDA Inspections - Dos Donts - Webinar By GlobalCompliancePanel Overview: The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectations - Webinar By Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out  more...

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration - Webinar By GlobalComp Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors,  more...

Introduction to Financial Risk Management - Webinar By GlobalCompliancePanel Overview: This 3 hour course of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Thursday, June 21, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - GlobalCompliancePanel Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

How to submit a 510k and get it cleared from FDA - Webinar By GlobalCompliancePanel Overview: This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA. Thursday, June 28, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel This webinar will discuss the FDA's current thinking on good practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging  more...

Use of Risk Management during Process and Design Validation - GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements - Webinar GlobalCompliancePanel Overview: Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Thursday, May 17, 2012 10: 00 AM PDT | 01: 00 PM  more...

Risk-Based Monitoring of Clinical Trials Say Goodbye to 100 Source Document Verify - Webinar By GlobalCompliancePanel Overview: The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data. Tuesday, May 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Writing Effective Clinical Evidence Reports Trial Data Medical Literature and Marketing Info - Webinar By GlobalCompliancePanel Overview: This presentation takes a step-by-step approach to writing a Clinical Evidence Report (CER) including how to write up a review of: The clinical trial data A well-designed literature review and Marketing information showing appropriate post market surveillance Tuesday, May 8, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

FDA Requirements for Device Labeling Development Contents Distribution and Changes - Webinar GlobalComplianceP Overview: Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible. Wednesday, May 16, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Corrective and Preventive Actions CAPA 10 Steps - Webinar By GlobalCompliancePanel Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Thursday, June 7, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

21 CFR PART 11 Complete Manual for Compliance Success - Webinar GlobalCompliancePanel Overview: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. Tuesday, May 15, 2012  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar GlobalCompliancePanel The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Construct and Manage the Technical File and Design Dossier - Webinar GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details  more...

Bullet Proof 510k Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Tuesday, June 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Medical Device Postmarketing Vigilance Reporting Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2. 12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." Tuesday, June 12, 2012  more...

Update on Unique Device Identifier for Device Manufacturers - Webinar By GlobalCompliancePanel Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions. Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Container Closure Systems and Bulk Freeze-Drying - Webinar By GlobalCompliancePanel This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques. Tuesday, July 17, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Scale-Up Cycle Transfer and Maximum Throughput Capability for Lyophilized Products - Webinar By GlobalCompliancePanel Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production  more...

Residual Moisture Testing of Lyophilized Products - Webinar By GlobalCompliancePanel This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives. Tuesday, June  more...

Lyophilization Process Development and Cycle Design with a Case Study - GlobalCompliancePanel Webinar Overview: This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive. Thursday, May 24, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product - Webinar By GlobalCompliance This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques. Wednesday, May 9, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Conducting Successful Product Complaint Investigations - GlobalCompliancePanel Webinar Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles - Webin Overview: This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Tuesday, April 24, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Training Practices for FDA Compliance - Webinar GlobalCompliancePanel Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on  more...

IT Infrastructure and Network Qualification Step-by-Step - Webinar By GlobalCompliancePanel Overview: Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. Thursday, June 21, 2012 10: 00 AM PDT | 01: 00  more...

Validation of Analytical Methods for FDA Compliance Step-by-Step - Webinar By GlobalCompliancePanel Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Wednesday, May 23, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Device Changes and the 510k - Webinar GlobalCompliancePanel Overview: The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. Wednesday, May 9, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Excel Spreadsheet Validation to Eliminate 483sGlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, June 5, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Efficient Computer System Validation - GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Tuesday, May 15, 2012 10:  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Medical Device Supplier Quality Agreements - Webinar By GlobalCompliancePanel Overview: The FDAa ™s Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement. This webinar explains the elements of a supplier quality agreement and its implementation. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Implementing Management Responsibility for Medical Devices - Webinar By GlobalCompliancePanel Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. Wednesday, June 6, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Leadership in Manufacturing Contamination Control - Webinar By GlobalCompliancePanel The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. Tuesday, June 5, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Aspects to Consider for Clean Room Qualification and Operation - Webinar By GlobalCompliancePanel Overview: Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated into the design. Tuesday, May 15, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems - Webinar By GlobalCompliancePanel Overview: Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Webinar By GlobalCompliancePanel In July 2010, the FDA announced to conduct a series of inspections related to 21 CFR Part 11. In meantime the program is still on-going. FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the guidance from 2003. Thursday, April 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Thursday, April 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Using Statistics to Determine Sample Size - Webinar GlobalCompliancePanel Overview: webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a  more...

Pharmaceutical Water System Use Monitoring Avoiding Problems by Doing It Right The Practicality of Real-Time Release - Webinar Overview: Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar GlobalCompliancePanel Overview: RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. Tuesday, April 17, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

510k Submissions Requirements Challenges and Successful Clearance - Webinar By GlobalCompliancePanel Overview: A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. Thursday, April 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - GlobalCompliancePanel Overview: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, April 18, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Avoiding an FDA Warning Letter with a Strong CAPA Program - Webinar By GlobalCompliancePanel Overview: The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA. Thursday, March 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

What to do if you get a FDA 483 Warning Letter - Webinar By GlobalCompliancePanel Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Thursday, March 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Zero Defects and the CGMPs - Pros and Cons - Webinar By GlobalCompliancePanel Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). Wednesday, April 11, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

IEC62304 - Development and Maintenance of Critical Software - Webinar GlobalCompliancePanel Overview: Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Wednesday, March 21, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

How to Prepare for Manage and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!  more...

Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...

Clean Room Microbial Load and Characterization of Microorganisms in the Clean Room Environment - Webinar By GlobalCompliancePane A summary of test methods will be covered, and a review of types of microorganisms that can be present, will be discussed. A general review of environmental niches where they may be present will be discussed. You will be introduced to the different methods available to conduct testing. Key areas discussed will be Compressed Air, Personnel Monitoring, Surface and Raw Material Monitoring.  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

Contingency Plan for Disasters - Are You Prepared - Webinar By GlobalCompliancePanel Most medical and dental practices are ill prepared for disasters. In addition to the enormous difficulty in returning to business following a disaster, OSHA and HIPAA rules now require that medical and dental practices have a plan of action that will ensure that patient data will not be lost and to also have a plan in place to provide a return to care for its patients. Tuesday, November 8, 2011  more...

Corporate Integrity Agreements Offer A Second Chance - Webinar By mentorhealth Health Care Providers that find unintentional coding or documentation errors and report them to their Medicare Contractors or Intermediaries or private payers should not worry about being subject to CIA's. Thursday, October 27, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Audits In The Health Care Industry - Getting Ready for an Outside Audit - Webinar By mentorhealth You need to attend in order to control your own destiny. Get involved up front instead of being a "sitting duck". Tuesday, October 11, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Privacy as a cultural issue what it means to HR or to Corporate Counsels or to Hospital Administrators - Webinar By mentorhealth Risks of HIPAA violations pale to the risks to employees, employers, and communities regarding conflicting loyalties, symptomatic over-valuation of privacy, and a clear understanding of where privacy and confidentiality need to be bartered for higher priorities of individual safety. Wednesday, October 26, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

HIPAA Compliance and Patient Care Where the Challenges are - Webinar By mentorhealth Dona ™t miss the opportunity to identify common privacy violations that make substantive critical difference in the safety of patients, staff, and families. Safety and privacy are partners in that if patients withhold information due to distrust in their information being confidential. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Specializing in Treating the Phobic Patient - Webinar By mentorhealth Treating the phobic patient is analogous to the clinician acquiring a new skill like implantology. It requires knowledge of the three primary medications used; the indications and contraindications. The only financial investment will be a pulse-oxymeter (to monitor vital signs during treatment). Tuesday, October 18, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Documentation Path to Home Health Compliance - Webinar By mentorhealth In the current environment of high deficits and economic instability, home health agencies must constantly be vigilant to ensure they are being good stewards of public dollars. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

2012 New and Changed ICD-9- CM Codes - Webinar By mentorhealth Don't miss this opportunity to learn about all of the ICD-9-CM changes for 2012. It is imperative that all coders stay current on changes in the official ICD-9-CM codes and be prepared to implement those changes by October 1st. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Treatment Planning Non-Surgical Periodontal Therapy Cases - Webinar By mentorhealth This one hour interactive webinar introduces both dentists and hygienists into the world of non-surgical periodontal therapy. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Dispel the Loss Leader Myth Blueprints to Increase Hygiene Department Services and Production - Webinar By mentorhealth You've tried getting new patients to fill the holes in your hygiene schedule....now its time for a new approach! Fill the holes with your existing patients by learning how to treatment plan non-surgical cases. Thursday, October 13, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Disaster Preparedness - How to be prepared for the unexpected - Webinar By mentorhealth Are you prepared enough to survive, let along successfully recover from a disaster? The physical devastating possibilities that can happen to your practice include fire, flood, earthquake, hurricane, tornado, tsunami, or worse. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

HIPAA Privacy Policies and Procedures Prepare for Updates and New Requirements - Webinar By mentorhealth Learn how having good policies and procedures and good documentation can make compliance easier. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Thursday, October 20, 2011  more...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Hazard Analysis FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. Wednesday, October 26, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Hazard Analysis A practical guide - Webinar By GlobalCompliancePanel If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Thursday,  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are  more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities. Tuesday, October 25, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

FDAs 2011 Draft Guidance on Financial Disclosure by Clinical Investigators - Webinar By GlobalCompliancePanel This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators. Thursday, October 13, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan 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  more...

CAPA Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Wednesday, November 16, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

The DHF DMR DHR and the Technical File Design Dossier - Regulatory Requirements - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, November 2, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel There is an on-going major shift in the emphasis of U. S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one  more...

Dental Impressions - The Time for an Extreme Makeover is Here - Webinar By MentorHealth Overview: With the traditional impression technique, even when the impression s looked acceptable to the clinician, problems surface when the lab calls and explains there is a problem with the conventional impression sent in or the model they poured up, that the margin was unclear, it did not draw, or there was not enough occlusal or axial reduction. Thursday, June 7, 2012 10: 00 AM PDT | 01:  more...

Simplify the Periodontal Therapy Coding Dilemma - Webinar By MentorHealth This one-hour webinar discusses the perplexing subject of proper coding for periodontal therapy procedures. Participants who are eager to learn about periodontal therapy coding will come away with a newfound understanding. Thursday, June 14, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Portable Devices and HIPAA Protecting information Avoiding Penalties and Surviving the Wave of Smart Phones iPads Laptops and Fl It seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used, including for health care purposes. New health care apps are being released all the time, and even good old e-mail is being used more and more to communicate, by providers and patients alike. Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

The Top Five Issues for Health Information Security Compliance What to do About Encryption Mobile Devices Disaster Recovery Docu Even though every health care organization is different and has different problems and different needs, most organizations face similar sets of security risks that must be mitigated. In fact, information from the US Department of Health and Human Services based on breaches and audits shows that the top five issues they find are similar to the ones voiced by the chief information officers of health  more...

HIPAA Accounting of Disclosures and EHRs How the Rules are Changing and What Your Systems Need to Provide - Webinar By MentorHea The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electonic PHI. First the current rule will be explained and issues pertaining to that will be  more...