Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

Christopher R DeVany
Jul 10, 2020 - 01:00 PM EST
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$249


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Description

The FDA has specific ideas about risk management that affect areas of your manufacturing operations.

Without a good overview of the latest guidances, you may not know how to readily identify potential hazards, apply proper risk evaluation requirements or conduct pre- and post-market assessments of your drug products and medical devices.

Areas Covered

·         Assessing requirements for risk evaluation and mitigation strategies (REMS)

·         Format and content of a REMS submission

·         Using a drug master file for shared-system REMS submissions

·         Benefit-risk counseling of patients using a drug with a REMS

·         Determining how to develop a risk minimization action plan

·         Identifying how to conduct a health hazard evaluation

·         Evaluating pre-marketing risk

·         Meeting FDA-adopted international standards

·         ISO 10993 on biological evaluation of medical devices

·         ICH Q9 on quality risk management

·         ICH Q10 on pharmaceutical quality systems

Webinar Events
Attend Live Webinar
Jul 10, 2020 - 01:00 PM EST

Duration: 60 Minutes

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Christopher R DeVany, President and CEO, Pinnacle Performance Improvement Wor

Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom.

He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His book, “90 Days to a High-Performance Team”, published by McGraw Hill has helped help executives, managers and team leaders improve performance. Mr DeVany has also been interviewed for various radio and television programs.

He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of the International Association of Facilitators, Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster’s International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader.

Chris has distinguished himself professionally by serving multiple corporations as manager and trainer of sales, operations, project management, IT, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in mergers and acquisitions, facilitating post-merger and acquisition integration, developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives.

Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.


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