Capa Web-based Seminars

Effective Corrective and Preventive Actions CAPA 10 Steps - Webinar By GlobalCompliancePanel Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Thursday, June 7, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Conducting Successful Product Complaint Investigations - GlobalCompliancePanel Webinar Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar GlobalCompliancePanel Overview: RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. Tuesday, April 17, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Avoiding an FDA Warning Letter with a Strong CAPA Program - Webinar By GlobalCompliancePanel Overview: The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA. Thursday, March 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Post-Design Medical Device Risk Management - Webinar By GlobalCompliancePanel In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Conducting Successful Product Complaint Investigation - Webinar GlobalCompliancePanel An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Thursday, March 22, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Conducting Successful Product Complaint Investigations - Webinar GlobalCompliancePanel This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel This presentation will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit. All these are done with the primary goal in mind: getting no audit findings. Thursday, November 3, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

CAPA Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. Wednesday, November 16, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural  more...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...

Developing an Effective CAPA Strategy through Root Cause Analysis of Failures Deviations - Webinar By GlobalCompliancePanel Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral,  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ..., underscore this increased emphasis. A valid closed-loop CAPA system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ... illustrate audit plans, system inventory, system audits, CAPA and remediation programs. Why should you attend: "Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? Areas Covered in the Session: * 21CFR  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...s Covered in the Session: * Understand how and why CAPA is tied in to product complaint investigations * Examples of tools currently being used to conduct investigations * How far and in-depth do you go with your investigations * What are current FDA "hot" buttons and trends * Benchmarks and best practices for investigations * How to become a "good" investigator  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...* Module 15 - Problem Solving-Deviations, Complaints, and CAPA * Module 16 - How about Part 11 * Module 18 - Current Trends * Module 17 - Review and Wrap-up Who Will Benefit: * Quality, quality control, regulatory affairs, operations working in the FDA regulated medical products industry (Pharma & Device) in the design, scale-up, regulatory approval, commercialization,  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ... actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document". Areas Covered in the Session: * The Revised ISO 14971: 2007 for Devices * ICH Q9 for Pharma * Product Hazard Analysis * Design, Process, and Use[r] Failure Mode, Effects and  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...e audit and follow up on the completed audit o CAPA and responses for the audit findings related to Part 11 - what to expect and handle the difference between 'regular' audits and Part 11 audits o Some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit * Module 4 - Audit Trails o Types of  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will give an example of how to develop a risk-based CAPA system. Why should you attend: In reviewing FDA Form  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...hys. The investigation system will be integrated with the CAPA and Change Control Systems. Why you should attend: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...le 14: Problem Solving-Nonconforming, Investigations, and CAPA systems Who will benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products. * Interdepartmental functions associated with scaling up and commercializing a new medical product * Suppliers  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...an -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities; Production and Process Controls * Suppliers, Contract Employees, Consultants * Some basic OSHA Concerns; ties to the cGMPs * Adverse Events Reporting Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D  more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/ PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel ...ical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an investigator's satisfaction, which has to center on CAPA. So the webinar  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection GlobalCompliancePanel 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...

Setting Up and Running a Tougher Supplier Audit Program GlobalCompliancePanel brings a new webinar on the topic of Setting Up and Running a Tougher Supplier Audit Program. Webinar will be on March 2, 2010. Webinar will be presented by John E Lincoln. Mr. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U. S. FDA responses.  more...

FDA Inspections What to Expect and How to Prepare GlobalCompliancePanel brings a new webinar on the topic of FDA Inspections: What to Expect and How to Prepare Webinar will be on March 3, 2010. Webinar will be presented by James Harris . Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60  more...