Cfr Web-based Seminars

GMP for Phase 1 Products - Webinar By GlobalCompliancePanel Overview: This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP. Tuesday, August 7, 2012 10: 00  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - GlobalCompliancePanel Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.  more...

21 CFR PART 11 Complete Manual for Compliance Success - Webinar GlobalCompliancePanel Overview: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. Tuesday, May 15, 2012  more...

Effective Training Practices for FDA Compliance - Webinar GlobalCompliancePanel Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on  more...

IT Infrastructure and Network Qualification Step-by-Step - Webinar By GlobalCompliancePanel Overview: Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. Thursday, June 21, 2012 10: 00 AM PDT | 01: 00  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Webinar By GlobalCompliancePanel In July 2010, the FDA announced to conduct a series of inspections related to 21 CFR Part 11. In meantime the program is still on-going. FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the guidance from 2003. Thursday, April 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

510k Submissions Requirements Challenges and Successful Clearance - Webinar By GlobalCompliancePanel Overview: A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. Thursday, April 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Zero Defects and the CGMPs - Pros and Cons - Webinar By GlobalCompliancePanel Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). Wednesday, April 11, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco ...2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your  more...

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates  more...

FDAs 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation to Eliminate 483s - GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar By GlobalCompliancePanel This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Tuesday,  more...

Excel Spreadsheet Validation to Eliminate 483s - Webinar GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

The Investigational Device Exemption When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel We will discuss the situation of the "sponsor/ investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that  more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel There is an on-going major shift in the emphasis of U. S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

21 CFR PART 11 Complete Manual for Compliance Success - Webinar By GlobalCompliancePanel FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

Excel Spreadsheet Validation to Eliminate 483 - Webinar By GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for yo  more...

Recent Major Industry CGMP Failures and How to Avoid Them U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). They are then required to translate those regulations into procedures and work instructions.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ... webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation  more...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized 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...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ... This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...g key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel ...ction. * Learn how to use Excela ™s built in 21 CFR Part 11 features. * Apply features required for GxP environments without programming macros. * Validate your application with minimal documentation. * Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users. Who Will Benefit: * All Excel users  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...s to the regulations for automated processes, found in 21 CFR 820. 70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of software application. The seminar explains FDAa ™s thinking and shows how to follow the guidance document. Lastly, we look at the electronic record aspects  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ... a good understanding of the technical requirements of 21 CFR Part and how to implement them. Areas Covered in the Session: * Leveraging a Part 11 Interpretation document * The Importance of Part 11 in Requirements and Specifications documents * The Role of Risk Assessment in Part 11 Compliance * Technical Controls for Electronic Records * The Many Flavors of Audit  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ... the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations. Reference material for easy implementation: * SOP: Recording of GLP and GMP Raw Data. * SOP: Retention and Archiving of Electronic Records * Checklist: FDA Record Retention and Retrieval  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...eminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF) guidances. The attendees will quickly learn and understand the quality systems principles through the many graphical  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ss are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources when making critical  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the  more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel ...ns such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...packaged" combination products. FDA proposes to create 21 CFR Part 4, subpart A, to codify the cGMP requirements that apply to combination products. What current good manufacturing practice requirements apply to my combination product? The proposed rule seeks to clarify which cGMP requirements apply when drugs, devices, and biological products are used to create combination products. The agency  more...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...required by BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared with the attendees to bring justification for team support  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ... Protocol Not Followeda (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved. Attend this Webinar to understand the proactive approach to define and manage Protocol Deviation/ Violation/ Exception. What is the approach to predict and prevent  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection- Webinar by GlobalCompliancePanel 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  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...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...ced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 24, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase,  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

Excel Spreadsheet Validation To Eliminate 483s GlobalCompliancePanel brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development,  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection ...alCompliancePanel brings a new webinar on the topic of 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection. Webinar will be on March 4, 2010. Webinar will be presented by Jasmin NUHIC. Mr. NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive  more...