The FDA has added a "Strategic Priorities" initiative that can assist companies to proactively address areas of GMP concern. This webinar discusses their latest / second “Priorities”, for the period of 2014 through 2018. It will address the major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial phases, product submissions and company response requirements.
All regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management. These “Priorities” signal continued changes in FDA focus that have a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success.
Why Should You Attend:
Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP good manufacturing practices. The FDA has added an audit initiative that can assist companies to proactively address areas of GMP compliance. This discusses their latest / second “Priorities”.
There is a major shift in the emphasis of the U.S. FDA cGMP compliance regulation audits, clinical trial expectations, product submissions and company response requirements. Some examples: Outsourcing and the new worldwide regional posts of the FDA; justification for sample sizes used in validations, etc. All regulatory areas are being reevaluated by the FDA. The same needs to be performed by a company's QA/RA and its senior management. These changes have a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success.
Ongoing negative publicity on pharmaceuticals, devices, as well as events in unrelated industries show many senior executives just don't get it, and this has put pressure on the Agency to "get tough on compliance / enforcement". This webinar show how companies must also “get tough on compliance” by an examination / review of FDA's "must-have's" for corporate cGMP compliance.
Areas Covered in this Webinar:
This webinar will educate you on FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on their ‘second’ published initiative, 2014 - 2018. It will prioritize on the wide 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. This analysis 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, regulatory science, global supply chain, product life cycle, sox compliance, biological issues and what the FDA and industry need to do internally.
An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past years will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA audit areas for required review or related industry problem areas. The result will form the basis for such a management review and a listing of likely milestones and tasks.
Anticipation and addressing of weak spots proactively will further establish a company as being "in control", and assist in timely review of submissions to the Agency, and in any compliance remediation efforts.
Mandated Areas for Annual Reviews
FDA's "Strategic Priorities" for 2014 – 2018
Tougher Regulatory Science -- What "Better Science" Really Means
Device, Pharmaceutical and Biological Issues
General CGMP Issues -- Strengthened Compliance
Safety / Integrity of Global Supply Chain
Heightened Supplier Issues
Product Life Cycle - FDA clearance / approval only the beginning
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
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