This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, their similarities, as well as the two different device classification schemes.
FDA's and the Customs and Border Patrol Service (CBP) has become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused.
GlobalCompliancePanel will hold a RAPS approved two-day, in-person seminar in Philadelphia on the topic, "Applying ISO 14971 and IEC 62304 - A guide to practical Risk Management" on November 7 and 8, 2013 (Thursday and Friday). Markus Weber, Principal Consultant with System Safety, Inc., will be the speaker at this two-day session.
GlobalCompliancePanel will hold a two-day, in-person seminar in Phoenix, AZ on the topic, "Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties" on October 24 and 25, 2013 (Thursday and Friday). Jim Sheldon-Dean, the founder and director of compliance services at Lewis Creek Systems, LLC.
GlobalCompliancePanel will hold a RAPS approved two-day, in-person seminar in San Diego on the topic, "Applying ISO 14971 and IEC 62304 - A guide to practical Risk Management" on August 1 and 2, 2013 (Thursday and Friday). Markus Weber, Principal Consultant with System Safety, Inc., will be the speaker at this two-day session.
GlobalCompliancePanel will hold a two-day, in-person seminar in Chicago on the topic, "Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties" on August 29 and 30, 2013 (Thursday and Friday).
"The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on June 4. Robert J. Russell, President of RJR Consulting, Inc. will be the Speaker at this 90-minute webinar.
GlobalCompliancePanel to hold two-day, in-person seminar in Philadelphia on the topic, "Statistical Process Control for Process Development and Validation" on May 23 and 24, 2013 (Thursday & Friday). Steven Kuwahara, Founder and Principal, GXP Biotechnology LLC, will be the speaker at this two-day session.
GlobalCompliancePanel to hold two-day, in-person seminar in Mumbai on the topic, "Software Validation for the New FDA Inspections" on July 1 and 2, 2013 (Monday and Tuesday). David Nettleton, an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation, will be the speaker at this two-day session.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "New EU Pharmacovigilance Directive and Regulations" on April 9. This 90-minute webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Variable Data" on April 11. This webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Attribute Data" on April 11. This webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
This course is about the Hazard Analysis and Critical Control Point (HACCP). It will introduce the role of the HACCP. It will start with a chronology of the HACCP program in the US food industry, in which it will cover important historical events and program milestones.
It is an irony of sorts that although companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493 are required by law to have Standard Operating Procedures (SOPs); there is no guidance on how to write, organize and maintain these critical guidance documents.
GlobalCompliancePanel to hold two-day, in-person seminar in Philadelphia on the topic, "Software Validation for the New FDA Inspections" on April 18 and 19, 2013( Thursday & Friday). David Nettleton, an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation, will be the speaker at this two-day session.
GlobalCompliancePanel to hold two-day, in-person seminar in San Francisco, CA on the topic, "Effective Complaint Handling, Medical Device Reporting and Recalls" on April 25 and 26, 2013 (Thursday & Friday). David R. Dills, a senior Regulatory & Compliance Consultant, will be the speaker at this two-day session.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on April 9, 2013.Kim Huynh-Ba, Executive Director of Pharmalytik will be the Speaker at this session, whose topic will be"Key Factors to develop an effective CAPA system".
"Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements from ICH Q10" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 21.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on March 20 on the topic, "Global Medical Device Adverse Event Reporting Systems in EU, Canada and US". Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at this webinar.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Japan -Regulatory Filing Requirements and Compliance Processes for Life Sciences" on March 20.
"Meet the U.S. FDA's Tougher Requirements for the 510(K)" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 20.
A RAPS pre-approved webinar on the topic, "Good Documentation Practices for GMP Operations" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on March 19. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
A RAPS pre-approved webinar on the topic, "Project Management for Computer Systems Validation" is being organized by GlobalCompliancePanel, a leading provider of regulatory and compliance continuing education training, on March 14.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinaron the topic, "Managing Your Medical Device Reporting (MDR) Program for Compliance Success",on March 13.
"Medical Device Adverse Event Reporting Systems in EU, Canada and US" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 6. This webinar, a 60-minute session, earns 1.00 RAC credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Disinfection and Clean room Cleaning in an FDA Regulated Environment" on March 5, 2013.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Complaint Handling in Compliance with FDA and ISO Regulations" on March 5. This 60-minute webinar earns up to 1.0 RAC credits towards a participant's RAC recertification upon full completion.
"Combination products" is a broad term. The FDA describes it in fairly straightforward terms thus: "Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products." Although simple in description, the complexity lies in the fact that there are very many combinations in the market, and they all have to be regulated.
Steven Walfish, President of Statistical Outsourcing Services will be the Speaker ata RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeon February 19, 2013. It will be on the topic, "Using Statistics to Determine Sample Size" .
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Outsourcing Management -Effective Contract Manufacturers, Supplier Evaluation, Approval and Monitoring", on February 21. Miguel Montalvo, President of Expert Validation Consulting, will be the speaker at this 90-minute webinar.
Good Automated Manufacturing Process (GAMP) 5 is a set of five important principles of automated manufacturing processes in the field of Life Sciences. Since it provides practical industry guidance on how to achieve compliant systems fit for intended use; it is considered the "how to" of a validated system in this industry.
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on March 21 and 22 at Mumbai, India.
"Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process" is the topic ofa RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on February 13.
In the course of his discussion, the presenter, David Nettleton will demystify Part 11 and the new European equivalent Annex 11. This session will put participants on the right track for using electronic records and signatures, which will help them to greatly increase productivity.
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Design of Experiments and Statistical Process Control for Process Development and Validation" on February 7 and 8 at Orange County, CA.
Many problems have arisen in the past when designing and scaling-up lyophilization cycles because this process was subjective, being more of an art than a science, and cycles were designed and scaled-up based on a "trial and error" approach.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Clean room Design, Certification & Validation" on February 7, 2013. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion.
Adaptive clinical trials, owing to their flexibility, help bring in the latest technological findings midway through into a clinical trial. This helps improve the end result quite dramatically.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize RAPS pre-approved webinar on the topic, "510(K): Format and Contents", on , February 6.Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at this webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon completion.
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on March 21 and 22 at Mumbai, India.
When preparing statistics for Quality Control and Process Validation, professionals are required to compare various sets of data. In this series on this topic, the expert, Dr. Steven Kuwahara has already covered the area of converting the process for comparing two sets of data.
Data from testing and measuring usually follow mathematical distributions other than normal distribution, or what is called the Bell-Shaped curve. Among these, the Poisson Distribution, which describes low frequency events, occupies a prime place.
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends.
Retention of records pertaining to drugs is a major issue in the drug industry. There is a lot of debate, discussion and even confusion on the period of time for which records need to be kept.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic; "Good Documentation Practice for GxP Environments"on January 15.John R. Godshalk, Senior Consultant at Biologics Consulting Group will be the Speaker at this session.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, "Complaint Handling and Management: From Receipt to Trending", on January 15.
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2013. Such a review will focus on the broad range of issues a company's senior management and QA-RA need to consider in their annual Management Review of their existing quality management system.
Regulatory agency audits are designed to evaluate your company's regulatory risk profile. In order to comply with GMP regulations, companies are required to self regulate their operations through regularly scheduled internal audits. Regulations also require the company's senior management be involved with these audits.
"GMP Expectations for Products Used in Early Phase IND Studies" is the topic of a 90-minute, RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 18. This webinar, at which Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the speaker.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize aRAPS pre-approved webinaron November 15.This course earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. Jeff Schwegman, Ph.D., founder and chief executive officer of AB BioTechnologies,will be the Speaker at this session.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinaron the topic, "Changes to Good Pharmacovigilance Practices in the EU"onDecember 13.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Cost-Effective Computer System Validation: Step-by-Step" on December 13. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion.
"Establish and Maintain an Effective Supplier Qualification Program" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeon December 13.David R. Dills, Regulatory and Compliance Consultant, will be the Speaker at this session.
"Responding to FDA 483's" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 11.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinar on the topic, "510(K): Format and Contents", on December 11.Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at this webinar, which earns up to 1.00 RAC credits a participant's RAC recertification upon full completion.
A RAPS pre-approved webinar on the topic, "Human Behavior in Cleanrooms and Controlled Environments" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider on December 11. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
"Root Cause Analysis and Documentation Requirements for CAPA" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 6. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
David Nettleton, FDA Compliance Specialist, will be the speaker at aRAPS pre-approved webinaron the topic "Excel Spreadsheets -Step-By-Step Instructions for Compliance" that is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider,on December 5.
A RAPS pre-approved webinar on the topic, "Change Control - Key to Successful cGMP Compliance" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 5. This webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
"Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner" is the topic of a 60-minute, RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 4. This webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizea RAPS pre-approved webinar o the topic,"FDA Inspections - Do's and Don'ts" onSeptember 25. Jeff Kasoff, RAC, Director of Regulatory Affairs at Life-Tech, Inc., will be the speaker at this 60-minute webinar.
A RAPS pre-approved webinar on the topic, "21 CFR Part 11: Auditing for Part 11 Compliance" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on December 4. This webinar earns up to 2.00 RAC credits towards a participant's RAC recertification upon full completion.
ARAPS pre-approved webinar on the topic, "Recalls & Vigilance -When to Report Complaints", is being organized on December 11by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider.This webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion, will have John Chapman as the Speaker.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing a RAPS pre-approved webinar on the topic, "Obtaining an FDA Investigational Device Exemption" on November 20. This webinar earns up to 1.0 RAC credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing a RAPS pre-approved webinar on the topic, "The DHF, DMR, DHR, and the Technical File-Design Dossier -USFDA and EU MDD Requirements" on November 14.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeaRAPS pre-approved webinar on November 13.The topic of this 60-minute webinar is "Design Control for Professionals", and the speaker will be John Chapman, Regulatory Affairs professional.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule"on November 6. Jasmin Nuhic, Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Peripheral Therapies), will be the speaker webinar.
John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the speaker at a RAPS pre-approved webinar on the topic, "Bullet-Proof Closed-Loop CAPA".
"South Korea: Navigating the Clinical Trial and Regulatory Environment" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize onOctober 31.
Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on October 25.
A RAPS pre-approved webinar on the topic, "Root Cause Analysis" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on October 24.
"Reprocessing REUSABLE Medical Devices -Cleaning & Labeling Requirements" is the topic of aRAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on October 23.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Laboratory Water Systems: Necessary Water Specifications and Validation Challenges" on October 23. Teri Soli, President of Soli Pharma Solutions, Inc. will be the speaker of this webinar which earns up to 1.5 RAC credits towards a participant'.
A RAPS pre-approved webinar on the topic, "FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements", will be organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on November 20, 2012.
Avoiding 483 Observations and Warning Letters" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing on October 17.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Process Validation Principles and Protocols for Medical Devices", on November 15. Jeff Kasoff, RAC, Director of Regulatory Affairs at Life-Tech, Inc., will be the speaker of this 60-minute webinar.
ARAPS pre-approved webinar entitled "Creating Material, Waste, and Personnel Flow Diagrams for Cleanrooms and Controlled Environments" is being organized on October 16 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will conduct a RAPS pre-approved webinar on the topic, "Statistical Procedures Needed for Compliance with the Guidance on Process Validation". The date of this webinar is November 14, and the speaker is Steven Kuwahara,founder and Principal of GXP BioTechnology LLC. This webinar earns 1.5 RAC
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) -Regulatory Documents Explained", on November 8.
"Validation of Bioanalytical Methods and Procedures for FDA Compliance" is the topic of a 75-minute RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on October 10.
A RAPS pre-approved webinar on the topic, "Calibration and Assuring Accurate Measurements" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on October 9. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA" on October 9.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Selling Medical Devices in the EU-Medical Device Directive, CE & FDA" on October 4.John Chapman, Regulatory Affairs professional, will be the speaker of this 60-minute webinar.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "510(k) Preparation, Submission, and Clearance"on October 3. David Lim, a certified professional for regulatory affairs (RAC) and a certified quality auditor (CQA); will be the speaker of this webinar.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "21 CFR Part 11 Compliance for Excel Spreadsheets" on October 2.
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Process Validation -current industry practices and FDA Guidance Document Review" on October 2.
A RAPS pre-approved webinar on the topic, "Developing and Maintaining Pre-marketing Master Regulatory Files" is being conductedon August 1 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider.
A RAPS pre-approved webinar on the topic, "Safety Critical Software -Software Risk Management" is being held by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider on October 4. This webinar earns 1.00 RAC credits towards a participant's RAC recertification upon full completion.
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