Effect Web-based Seminars

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...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...ntrol program has been implemented without regard for the effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy compliance.  more...

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel .... Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the regulations directly apply, which means that more entities than ever need to adopt the proper HIPAA Security policies and procedures to be in compliance. HHS compliance audit activity and enforcement penalties are both increased, especially in instances of willful  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ... American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...ntrol program has been implemented without regard for the effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...eld problems indicate that change control and ita ™s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U. S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...viations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. The investigation of deviations is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...y Rule, in place and as proposed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health information. While many entities have gone through the processes necessary for HIPAA Security Rule compliance, many are only partially in compliance and  more...

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

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT  more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...ssification and conformity paths using the MDD version in effect after March 2010. The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based system set forth in Schedule 1 of the CMDR. The Global Harmonization Task Force (GHTF) has a guidance document on medical device risk classification that uses  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need  more...