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Webinar Packs
News
Recalls and Safety Alerts: Warning on Proton Pump Inhibitors and Fracture Risk

Recalls and Safety Alerts: Lifeline and ReviveR AED Battery Packs Recalled

Recalls and Safety Alerts: Update on Counterfeit Polypropylene Mesh

Recalls and Safety Alerts: Thrombosis with Off-Label Promacta Use

Recalls and Safety Alerts: Severe Liver Injury with Orlistat (Xenical, Alli)

Preventing Medical Errors: Dosing Errors with Certain Oral Syringes

Preventing Medical Errors: Reporting Adverse Events to MedWatch

New from FDA: Help FDA Stop ?Bad Ads?

Recalls and Safety Alerts: Warning on Proton Pump Inhibitors and Fracture Risk

Recalls and Safety Alerts: Lifeline and ReviveR AED Battery Packs Recalled

Recalls and Safety Alerts: Update on Counterfeit Polypropylene Mesh

Recalls and Safety Alerts: Thrombosis with Off-Label Promacta Use

Recalls and Safety Alerts: Severe Liver Injury with Orlistat (Xenical, Alli)

Preventing Medical Errors: Dosing Errors with Certain Oral Syringes

Preventing Medical Errors: Reporting Adverse Events to MedWatch

New from FDA: Help FDA Stop ?Bad Ads?
Featured Speakers
Dr. Mike Long
Director,
KPM International Associates
David N. Muchemu
Founder and CEO,
Quality systems International, (QSi) LLC
Vincent M. Dailey
Executive Vice President,
Quality Assurance Systems, Inc.
Live Webinars
37 webinars found.
Edwin L Bills
Use of Risk Management to Meet Requirements of IEC 60601-1
This presentation will examine the requirements of IEC 60601-1 for use of ISO 14971 risk management and interpret those requirements.
Live  Thursday, August 26, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
David R. Dills
Construction of the European Drug Master File (eDMF) for Regulatory Agencies
Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure.
Live  Tuesday, August 31, 2010 09:00 AM PDT | 12:00 PM EDT,  Duration:60 Minutes
$245.00
Vincent M. Dailey
Conducting Value Added Audits of Technical Service Providers
This presentation will address conducting value added audits of technical service providers (TSPs) providing services for and/or in support of clinical trials and programs.
Live  Tuesday, August 31, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
David N. Muchemu
Designing a Change Control System that Meets and Exceeds Compliance Requirements
This webinar equips the attendee with information required to design, manage, and sustain a change control system that meets and exceeds FDA requirements.
Live  Tuesday, August 31, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Kerry Paul Potter
Good Documentation Practices for GMP Operations
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.
Live  Thursday, September 2, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Jeff Kasoff
Understanding Corrective and Preventive Action, and Elements of a CAPA System
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
Live  Thursday, September 2, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Anthony G. Tarantino
Corporate Governance & Compensation in Risk Management
This session will provide an overview of the major tenants of corporate board governance, structure, organization, and composition and how each of these relates to an enterprise's ability to balance risk and opportunities while acting in an ethical and pr
Live  Tuesday, September 7, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$165.00
Edwin L Bills
Post-Design Medical Device Risk Management
In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements.
Live  Tuesday, September 7, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Angeline Benjamin
Improving Sanitation Standard Operating Procedures in the Food Industry
Foodborne illness is often traced to improper cleaning and sanitizing of food equipment and the environment.
Live  Tuesday, September 7, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$165.00
John E Lincoln
Key Modules of an Effective CAPA SOP
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, especially CAPA.
Live  Wednesday, September 8, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Nancy Duarte-Lonnroth
Effective & Essential CAPA process to avoid FDA 483
How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers.
Live  Wednesday, September 8, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Pauline McGregor
Verification of Pharmacopeia Methods
Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods.
Live  Thursday, September 9, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Steve Jolley
Signal Detection and Data Mining
This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques.
Live  Thursday, September 9, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Dr. Ludwig Huber
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourse
On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11.
Live  Thursday, September 9, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
Dan OLeary
Understanding Acceptance Activities for Medical Devices
Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
Live  Tuesday, September 14, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
John Bauer
Physical Properties Analytical and Screening Techniques
The chemical composition of the active ingredient of a pharmaceutical dosage form determines the efficacy and stability of the formulation however during manufacturing it is the physical properties of the formulation components that are critical in the un
Live  Tuesday, September 14, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$165.00
Max Lazar
How to Audit API Manufacturers and Suppliers
This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions.
Live  Tuesday, September 14, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Gerry O'Dell
Troubleshooting ethylene oxide (EO) processes
Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification.
Live  Wednesday, September 15, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Carlos M. Aquino
Law Enforcement and Pain Management
Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that are dispensed, or prescribed by a physician as part of a pain treatment plan.
Live  Thursday, September 16, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 + 15 Minutes Q&A
$245.00
Jeff Kasoff
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
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.
Live  Thursday, September 16, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Edwin L Bills
Why Medical Device Companies Receive Warning Letters
The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical d
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Pauline McGregor
Quality by Design (QbD) and Analytical Methods
As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification?
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
Barbara A. McLaughlin
Auditing Computer System Validation Materials
This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation.
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
David R. Dills
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] su
Live  Tuesday, September 21, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Dr. Norman F. Estrin
The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims
Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance.
Live  Wednesday, September 22, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
John E Lincoln
Compiling the Design History File, and Technical File / Design Dossier
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD.
Live  Wednesday, September 22, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Nancy Duarte-Lonnroth
Preparing for FDA Inspections in a Changing Regulatory Environment
Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years.
Live  Wednesday, September 22, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Angeline Benjamin
Developing and Implementing an Effective Product Specification
A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.
Live  Thursday, September 23, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$165.00
Anthony G. Tarantino
Environmental and Product Compliance - Sustainability
Many leading organizations have recognized the need to manage environmental risks and demonstrate a commitment to sustainability and related environmental compliance.
Live  Thursday, September 23, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$165.00
Dan OLeary
Outsourced processes and ISO 9001:2008
In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements.
Live  Tuesday, September 28, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
Dr. Mike Long
Robust Process Validation for Medical Devices
One of the most common reasons noted by the FDA for recalls of medical device is improper validation.
Live  Tuesday, September 28, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Kerry Paul Potter
Preparing for and Surviving an FDA Inspection
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state
Live  Tuesday, September 28, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
David R. Dills
How to Manage a Product Medical Device Recall Efficiently and Effectively
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
Live  Thursday, September 30, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Jeff Kasoff
Development, Management, and Operation of an Effective Supplier and Internal Auditing System
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day.
Live  Thursday, September 30, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
John Geigert
Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking
Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical.
Live  Thursday, October 7, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Jeff Kasoff
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Co
Document control can be a time- and paper-consuming process.
Live  Tuesday, October 12, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Bernice Russell Bond
The HITECH Acts Impact on HIPPA
The new requirements of the HITECH Act have a significant impact on the privacy and security of health information.
Live  Thursday, October 14, 2010 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$165.00
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