|
Overview
Quality Risk Management is considered by the FDA and other international regulatory agencies as a "valuable component of an effective quality system." The industry is aware that the ICH Q9 guideline has already been approved for implementation by the regulatory agencies but the question still is - How do we comply? Where do we start? The presentation will address how to develop an effective QRM Policy and corresponding plans including the strategies for selecting the processes/areas to be targeted for the initial QRMs, the selection of the QRM team and the criterias for considering the QRM process completed.
Who Should Attend
Quality, Manufacturing, Engineering and Top Management
Industry: Pharmaceutical,Biotechnology, Medical Device
Learning Objectives
Attendees will learn how to:
• Develop and implement a policy for a Quality Risk Management Program
• Determine how to select the direct-impact systems and key processes to apply your policy
in a formal/documented process
• Develop a specific QRM Plan for the area selected
This webinar will identify challenges/issues and discuss Solutions being offered
Challenge is comply with the ICH Q9 guideline in a practical but effective manner by selecting key targets for controlling the risks and documenting the process adequately.
Presenter
Miguel Montalvo
Expert Validation Consulting, Inc.
Miguel Montalvo, B.S. Chem. Eng., MBA, has over twenty-seven years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology and medical device industries including extensive expertise on development and implementation of quality functional procedures (QA/QC), Quality Systems, GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations, Change Control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.
Before starting EVC, Mr. Montalvo held senior level positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations in companies such as AAC Consulting Group, Inc, Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. His experience includes roles in the manufacturing side but also from the supplier point of view as QA Manager for the Custom Systems Division of Millipore Corp.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics for organizations such as IVT, PDA-TRI, CfPIE and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications and have been published as an author of specific chapters in several design/quality/validation related internationally-recognized reference books. He is a previous member of the Journal of Validation Technology editorial board and a current member for the last five years of the PDA Annual Program Committee for their Annual meetings.
Registration Fee
Individual: $225
Group:
2 people: $180.00 each
3 people: $150.00 each
4 people: $120.00 each
5-10 people: $100.00 each
11-15 people: $70.00 each
16-20 people: $60.00 each
21+ people: Call for pricing
Register by December 31and receive 30% discount off above prices.
|
Events
