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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
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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
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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
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Signal Detection and Data Mining in Pharmacovigilance
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
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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
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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 unit operations.
Live
Tuesday,
September 14, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
$165.00
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Auditing 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
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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
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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
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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 device companies.
Live
Tuesday,
September 21, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
$245.00
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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
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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
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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)] submission to FDA.
Live
Tuesday,
September 21, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
$245.00
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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
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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
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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
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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 of control.
Live
Tuesday,
September 28, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
$245.00
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Managing 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
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How to Survive a DEA Audit or FIND=FINE
This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals.
Live
Thursday,
September 30, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:2 Hours
$245.00
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Defining and Managing Protocol Deviation/Violation/Exception
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly.
Live
Thursday,
October 7, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
$195.00
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Introduction to Risk Management
This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend.
Live
Tuesday,
October 12, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:3 Hours
$395.00
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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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Revamping the 510(k) Clearance Process-Understanding FDA's Proposals
The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making.
Live
Wednesday,
October 20, 2010
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
$245.00
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Call: 800-447-9407 
Fax: 302-288-6884
