FDA's New Enforcement of 21 CFR Part 11

Slides:



Advertisements
Similar presentations
Tamtron Users Group April 2001 Preparing Your Laboratory for HIPAA Compliance.
Advertisements

21 CFR Part 11 course syllabus / Ilan Shaya 21CFR Pat 11 | Objective | Audience |Course Outline | Details 15-16/7/2013.
Audit of IT Systems SARQA / DKG Scandinavian Conference, October 2002, Copenhagen Sue Gregory.
JOIN US IN BUILDING THE FUTURE. Audience So how many auditors are there here today? How many Design and Construction Members? How many – manufacturing,
Biomedical Auditing. The Biomedical Auditor works with medical devices, including in vitro diagnostics and biologics that are regulated as medical devices.
Introduction to Regulation
Laboratory Personnel Dr/Ehsan Moahmen Rizk.
Computer Security: Principles and Practice
Chapter 11 OFFICE MANAGEMENT.
Supplementary Training Modules on Good Manufacturing Practice
21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004 NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION.
CARE MANAGEMENT SOLUTIONS Case Management Utilization Management Disease Management Population Management Prevention Programs Wellness Programs Data Analytics.
QC/QA Mary Malarkey Director, Division of Case Management Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research March.
Session 6: Data Integrity and Inspection of e-Clinical Computerized Systems May 15, 2011 | Beijing, China Kim Nitahara Principal Consultant and CEO META.
Personnel Basic Principles of GMP Workshop on
11/2/991 CDER’s 21 CFR Part 11 Implementation Study Greg Brolund Associate Director, Office of Information Technology, CDER/FDA.
Top Tactics for Maximizing GMP Compliance in Blue Mountain RAM Jake Jacanin, Regional Sales Manager September 18, 2013.
The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.
QC | Slide 1 of 16 June 2006 Good Practices for Quality Control Laboratories P art 4: Inspecting the laboratory Supplementary Training Modules on Good.
August 22, 2002 THE HIPAA COLLOQUIUM at Harvard University A. John Blair, III, MD Chairman and Chief Executive Officer Taconic IPA, Inc. Fishkill, NY HIPAA.
Steve Stich Director Safety and Inspection Standard 6 Breakout Session Compliance and Enforcement Program March 12, :00am – 12:00 pm Julie Loera.
CLIA COMPLIANCE. What is CLIA? In 1988 Congress turned its attention to deficiencies in the quality of services provided by the nation’s laboratories.
Validation of Computerized Laboratory Systems
DRAFT Richard Chandler-Mant – R Consultant The Challenges of Validating R Managing R in a Commercial Environment.
Regulatory Update Ellen Leinfuss SVP, Life Sciences.
Kyle McDuffie, Vice President Beckman User Meeting 2001 Delaware. Orlando. Holland. UK Instrument Integration and Regulatory Compliance.
2 YBuy Procurement Application Web-based application that calls SAP functions to create purchase requisitions and purchase orders Access requires a valid.
Fourth Annual Medical Research Summit Concurrent Session 4.05 – Managing CROs and SMOs from a Compliance Perspective Michael SwiatochaAprill 23, 2004.
Device Clinical Trials and More… Michael E. Marcarelli, PharmD Director, Division of Bioresearch Monitoring Office of Compliance Center for Devices and.
FDA 483 and Warning Letter Interpretation with real Case Studies
OSHA Office of Training and Education1 Introduction to OSHA.
1 Importance of Instrument Validation for Accredited Food Export Testing Labs.
FDA Docket No. 2004N-0133 Themes for Renewal of 21 CFR Part 11 Rule & Guidance by Dr. Teri Stokes, GXP International
PERSONNEL TRAINING IN BIOANALYSIS DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA.
IDENTITY THEFT. RHONDA L. ANDERSON, RHIA, PRESIDENT ANDERSON HEALTH INFORMATION SYSTEMS, INC.
Lecture Topic 4: Good Manufacturing Practices (GMPs)
HIPAA PRACTICAL APPLICATION WORKSHOP Orientation Module 1B Anderson Health Information Systems, Inc.
FDA Public Meeting on Electronic Records and Signatures June 11, 2004 Presentation of the Industry Coalition on 21CFR Part 11 Alan Goldhammer, PhD Chair.
CM220: Unit 1 Seminar “You must be the change you wish to see in the world.” ~ Mohandas Gandhi.
Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments Audio Seminar Ludwig Huber Fax.:
OSHA – What to Expect When You’re Inspected (Following Federal Guidelines)
Legal Aspects of GHS Implementation Compiled by Goh Choo Ta.
United States Department of Agriculture Food Safety and Inspection Service Within Establishment Public Health Risk-Based Inspection for Poultry Slaughter.
FDA Facility Evaluation Douglas Stearn Deputy Director for Policy and Analysis Office of Compliance Center for Drug Evaluation and Research.
2016 MFRPS: Changes To Standard 10 Guy F. Delius, R. S. CSO Food and Drug Administration Office Of Partnerships Standards Implementation Staff February.
EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11.
| |
Webinar On Transfer of Analytical Methods and Procedures according to USP 1224 Presented By Dr. Ludwig Huber Webinar On Transfer of Analytical Methods.
, International Regulatory and Health Authorities Inspections Maria Santaella Sr. Quality Director Janssen Ortho LLC Jansen Cilag Manufacturing LLC Gurabo,
ValGenesis Closed Loop Change Management ValGenesis, Inc Christy Street, Fremont, CA Ph:
CM&C Inspections The Pre-Approval Inspection (PAI) in the US 27 May 2010.
WHO - PSM Basic Principles of GMP Documentation - Part 1 Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4 March 2005 Maija.
Responsibilities of Test Facility Management, Study Director, Principal Investigator and Study Personnel G. Jacobs Belgian GLP Monitorate Zagreb, 17 December.
©2015, Region One Education Service Center Curriculum Advisory Council Meeting March 26, 2015 EDGAR Uniform Grants Guidance Office of School Improvement,
TRANSLATION & LOCALIZATION SERVICES Certified Provider Providing Local Translations To Our Global Partners.
1 Training the FDA on: eSystems Used in Clinical Trials SEC Associates, Inc.
Analytical Method Validation Under Good Laboratory Practices (GLPs) Webinar Details Date : September 02 nd Friday 2016 Time : 01:00PM ET / 10:00AM PT Duration:
FDA 21 CFR Part 11 Compliance
FDA's Two New Draft Guidance on Software and Device
FDA Inspections Stephen Joseph Joy’s Quality Management Systems
Preventing Medical Device Recalls
Technology Transfer / Consent Decree Remediation
FACILITY SECURITY PLANS (FSP’s)
Gluten – Free Labelling with a Special Focus on Fermented, Hydrolyzed or Distilled Foods: How to Prove & Display It Correctly Webinar Details Date : September.
Computer System Validation
QA Reviews Lecture # 6.
RASG Informational Session
Tips for Resume and Cover Letter Writing
Radiopharmaceutical Production
Panel discussion GMP inspection process – Health Canada
Presentation transcript:

FDA's New Enforcement of 21 CFR Part 11 Speaker: Ludwig Huber| Date: 12th April 2016 | 10:00 AM PST | 01:00 PM EST Contact Us : Email: support@grcts.com | Tel: +1-248-233-2049

Description: FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

Areas Covered in the Session: FDA's current inspection and enforcement practices FDA's new interpretation: learning from FDA inspection reports Strategy for cost-effective implementation of Part 11: A six step plan Recommended changes to existing Part 11 programs to reduce costs Justification and documentation for the FDA and your management Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management. Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues. How to prepare your company for Part 11 Inspections

Who will benefit: IT managers and system administrators QA managers and personnel Analysts and lab managers Validation groups Software developers Validation professionals

Instructor Profile : Ludwig Huber, Ph.D., is the director of Lab compliance and  editor of w.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies.