This webinar will be highlighting the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers a summary review of relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of the methods for effective implementation - - - - - - more details

This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance - - - - - - more details.

This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations the factors under actual conditions of use which impact method performance and make method verification necessary will be addressed - - - - - - more details.

This webinar addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in ICH Q10, Pharmaceutical Quality System, and supported in the FDA Guidance to the Industry, Quality System Approach to Pharmaceutical CGMP Regulations.
This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems - - - - - - more details.

This session will address risk-based approaches to cleaning validation studies that reduce costs by using ICH Q9 and recent FDA comments and observations as a foundation. Case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices - - - - - - more details.

This seminar will discuss the evolution the interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10 - - - - - - more details

FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter.For example; a manufacturing engineer may recognize that an Excel spreadsheet could reduce the possibility of error in a manual calculation. On its own, the spreadsheet would be a valuable Preventive Action. However if the spreadsheet is not validated, approved, and documented properly it may create a problem during an FDA inspection. An unvalidated spreadsheet violates the QSR requirements for automated processes.
If manufacturers don’t understand the regulations, they could create regulatory problems that are will be hard to fix. Attend this webinar to know FDA requirements for Excel spreadsheets used in production or the quality system - - - - - - more details.

Good monitoring practices for medical devices are an integral part of product development. Keeping abreast of new scientific knowledge and global regulatory procedures related to advances in applied clinical research is essential to the success of the medical device industry. This course offers an opportunity for clinical researchers, industrial engineers, and healthcare professionals to gain an in-depth understanding of the regulatory process in medical device applications, as well as, the global regulatory framework as it relates to their product’s technology and market. This course provides comprehensive, up-to-date knowledge of regulatory processes contained in U.S. and international regulations, standards, and guidelines. The guidelines of the International Conference on Harmonization (ICH) will receive special attention throughout the course. The course will also prepare attendees to plan and execute effective and compliant method validation plans - - - - - - more details.

Companies budget and spend money in many different ways to meet compliance needs. These expenditures range from capital investments to one-time operating and on-going expenses. They include the costs to develop, implement and support the policies and programs necessary to meet the ever-changing requirements set forth by FDA in the Code of Federal Register.
This course will give you practical ways to analyze and optimize your cost of compliance, using examples based on current trends in the pharmaceutical and biotechnology industries. You will be provided with references for following the trends in compliance, including key areas where FDA is focusing resources, in order to keep your analysis current - - - - - - more details.

The 21st century has seen the introduction of increasingly diverse and competitive single-use technologies for Bioprocessing. This case study will highlight the extensive implementation of disposable filters, vessels, connectors, mixers, sampling devices and bulk storage containers in a GMP facility. The use of disposable technologies enabled facility design and construction in only 12 months at a modest cost of only $13 million.
A hybrid approach to facility design was employed to leverage the benefits of conventional equipment by augmentation with new disposable technologies. Disposable technologies benefited the project through reduced capital outlay, shorter equipment lead times, faster construction and rapid startup, enabling aggressive cost and timeline targets to be met. Disposable technologies enhanced GMP operation by offering superb control of process stream contaminants such as endotoxins and bioburdens - - - - - - more details.