Biologics Web-based Seminars

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel ...ents and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations  more...

Title 21 Code of Federal Regulations for Food and Drugs - Webinar By GlobalCompliancePanel Overview: United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. Thursday, March 29, 2012 10: 00 AM PST | 01: 00 PM EST  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...

The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel 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...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...s, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for routing, managing, approving and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and archiving. The U. S. FDA has eliminated it's "selective enforcement" policy and is looking for proper implementation of  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...

Pharmaceutical and Biologics Facility Design FDA and Regulatory Aspects by gcp This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect.  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...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...s, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though control of computer for individuals having disabilities restricting hand or eye movement / coordination. The U. S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: 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. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: 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 company-wide 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  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...es in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this process has successfully prepared several pharmaceutical companies to answer this  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...s primary validation standard brings U. S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: 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. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel Overview: Both the U. S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...luding Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include: * Validation managers and personnel * Engineers involved in water system design and installation * Utility operators and their managers involved in maintaining and sanitizing water systems * QA managers  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...luding Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include: * Engineers involved in water system design * Utility operators and their managers involved in maintaining and sanitizing water systems * QA managers and personnel involved in establishing water quality  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...ents and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine 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. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...yses, the new regulation states." FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold. Manufacturers generally must also obtain FDA approval before making changes to labeling information. However, in limited circumstances, companies can revise or supplement their warning labels prior to  more...

Process Validation for Drugs and Biologics ... webinar on the topic of Process Validation for Drugs and Biologics. Webinar will be on March 17, 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 countries around the world. During his  more...