Enforcement Web-based Seminars

Early Intervention Field Trauma Training ...ers (e. g., fire/ rescue, emergency medical services, law enforcement) as well as mental health and health care professionals will benefit from Field Trauma training. This is an entry-level program and no pre-requisites are required to receive the Field Trauma designation other than successful course completion. Participants will learn about on-site responding and learn how to respond to a  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...ctions and security safeguards and how BAs are subject to enforcement and penalties directly by HHS. Learn how Health Information Exchanges, Regional Health Information Exchanges, and e-Prescribing gateways are now considered to be Business Associates. Find out about how new limitations on marketing and fund-raising may change how entities can reach out to individuals. Learn all about how  more...

Supply Chain Integrity and Security - Webinar By GlobalCompliancePanel The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...d archiving. The U. S. FDA has eliminated it's "selective enforcement" policy and is looking for proper implementation of the control of electronic records and electronic signatures, that can withstand legal review in a court of law. Companies may try to say they are using "hard copies" as their controlled documents, but this is increasingly becoming a wrong belief as employees use the  more...

Surviving a DEA Inspection by a Hospice Program BY GCP The Drug Enforcement Administration (DEA) has been focusing on the prescribing of Schedules II narcotic substances by practitioners caring for their patients in a certified Hospice Program where narcotic drugs are prescribed for the individual patient.  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...view: In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...to be in compliance. HHS compliance audit activity and enforcement penalties are both increased, especially in instances of willful neglect of compliance, if, for instance, your organization hasn't adopted the complete suite of information security policies and procedures needed for compliance. Learn what it takes to get in compliance and stay there, even as your operations and  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...c signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design,  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...Associate Agreement * Find out about the new, higher enforcement penalties * Learn about the new violation categories * Learn about being prepared for a HIPAA Compliance Audit Agenda: * Old Ways, New Ways - Changes to the Rules o Origins of Changes to Business Associate Rules o New Definitions of Business Associates o Contractors of  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...to best document your incidents and breaches to withstand enforcement audits. Areas Covered In the Seminar: * Learn about the HIPAA Breach Notification Rule * Find out what is a breach * What to do to prevent a Breach * What to do to prepare for a Breach * What to do when a Breach occurs * What you have to report, to whom ,and when * How to avoid Breach  more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...he FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...nts o The guidance document + Enforcement discretion + Electronic records . . . # in place of paper format # in addition to paper format # records submitted to FDA in electronic format Who Will Benefit: Attendees should have knowledge of manufacturing and quality system  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...h the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion). Since the focus of any DEA investigation is the legitimacy of a prescription, the initial target is the pharmacist who fulfilled the prescription. The pharmacy may be inspected in order to determine their handling of controlled substances purchased  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ...ents for raw data and meta data * FDA Inspection and enforcement practices * Recommendations from industry task forces: GAMP/ ISPE guides * Definition of raw data: original records vs. standard electronic formats, paper print-outs * Ensure and demonstrate integrity of raw data * The importance of risk assessment for the management of raw data * Electronic record  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...gulations. It is true that the FDA establishes policy for enforcement of the regulations. It should be remembered the regulations came from industry and furthermore, that the regulations are the minimum requirements. When the pharmaceutical GMP's were issued, it was frequently stated that the regulations would result in only a mediocre or average quality system. This is because more emphasis  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...r restricting and accounting of disclosures and increased enforcement activity. All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review their HIPAA compliance, policies, and procedures to see of they are prepared to meet the changes in the rules. Covered entities that use electronic health records (EHRs) will need to meet  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ... put pressure on the Agency to "get tough on compliance / enforcement". This webinar will trigger such a response by an examination / review of 101 must-have's for corporate compliance. Areas Covered in the Session: * Mandated Areas for Annual Reviews * The Master Validation Plan -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities;  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ...ing of how to comply with FDA requirements. Potential FDA enforcement actions regarding OTC drug labeling will also be covered. Areas Covered in the Session: * OTC Drug Labeling regulations: background and requirements * Drug Facts labeling * OTC Monographs and their importance * Conditions under which OTC Drugs can be marketed in the U. S.A. Who Will Benefit: Anyone  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...c signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design,  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003  more...