Engineering Document Management for Simplified Compliance & Validation with Merck, IPS-Integrated Project Services, and Synergis Software

Register free: https://www.pharmtech.com/pt/document

Event Overview:
Life Sciences companies require centralized access and control of GxP documents and CAD drawings to improve quality processes and simplify compliance and system validation for FDA 21-CFR Part 11 and EMA Volume 4, Annex 11.

Join Merck, IPS, and Synergis Software on November 9th to learn how Merck is leveraging the Synergis Adept platform to address these issues while driving standards and best practices.

Key Learning Objectives:

You will gain insights to align your teams on a centralized source of truth, simplify document access, automate workflow, provide an extensive audit trail, and maintain regulatory compliance.
Discover how engineering document management and system validation services can help you:

• Lower the cost and effort of compliance and validation
• Reduce risk of noncompliance with streamlined audits
• Eliminate costly mistakes and safety issues
• Simplify collaboration and accelerate projects

Who Should Attend:

Any organization in a regulated industry, including:

• Pharmaceuticals
• Biotechnology-based food and medicine
• Animal health
• Medical devices
• Bio-medical technologies
• Cell and gene therapy
• Nutraceuticals
• Cosmeceuticals

Alternative markets –

• Food processing
• Chemical
• Petro chemical

Energy and Utilities

• Facilities
• Operations
• Engineering
• Program Management

Roles/Titles

• Manager, Director, VP of Facilities
• Manager, Director, VP of Operations
• Manager, Director, VP of Engineering
• Plant Manager

Speakers:

Ray Kastle
Associate Director, Supply Chain, Associate Director, Maintenance Excellence
Merck

Ray Kastle joined the US Navy shortly after high school and became a nuclear reactor operator on nuclear submarines. After eight years Ray transitioned to civilian life with an honorable discharge. Ray then worked for a commercial nuclear power plant for the next 10 years, starting as an instrument technician, and subsequently becoming a maintenance supervisor, senior supervisor, composite crew supervisor, test engineer, and work group coordinator. Transitioning to the pharmaceutical industry, Ray held positions as instrument engineer, senior supervisor, business engineer, reliability engineer, senior engineer, and currently acts as the supply chain associate director in manufacturing IT. Ray has extensive experience with various maintenance and engineering computer systems, and currently act as a liaison between the business and IT for global applications.


John Niziolek
Associate Director of Computer Systems Validation, Data Integrity & Medical Gases
IPS-Integrated Project Services

Mr. Niziolek is an innovative and creative professional with 20+ years of management and working experience in commissioning, qualification, and validation of pharmaceutical, laboratory, clinical, and research and development facilities. His experience includes strategic and practical application of regulatory principles for computerized systems, data integrity, infrastructure, cloud computing, equipment, production controls, and automation platforms for clients. John leads the IPS CSV & DI practice as well as the Medical Gases practice.

Scott Lamond
VP, Marketing
Synergis Software

A Partner and member of the executive team, Scott Lamond brings more than 30 years of marketing, sales, and channel experience to Synergis Software. Scott was instrumental in the creation of Synergis Software in 2001, and his passion and focus is on strategies to position Adept software as the global leader in engineering document management for the energy, process, life sciences, and mining industries. Lamond has been immersed in CAD, PDM, PLM, and ECM markets since 1991 and has helped hundreds of companies transform their work processes from a state of chaos to one of clarity and automation. Customers include Dow Chemical, Eversource Energy, Nucor, General Mills, Merck, Mosaic, and the US Coast Guard. He holds a degree in business management and marketing from Canisius College, and currently resides in the suburbs of Philadelphia, Pennsylvania. Beyond his Synergis mission, Scott Lamond is a practitioner and teacher of Ashtanga Yoga and is passionate about helping others improve their quality of life through wellness initiatives.

Register free: https://www.pharmtech.com/pt/document