Standard Operating Procedures (SOP's) play a pivotal role in shaping the daily routines of pharmaceutical professionals. SOPs are not just documents; they're your commitment to regulatory agencies. Join our seminar to demystify the art of crafting SOP's that strike the perfect balance between detail and clarity. Gain insights into how well-structured SOP's can elevate training and job performance while avoiding the pitfalls of poorly articulated procedures.
At SOP Synergy 2023, we'll equip you with the tools of process excellence and guide you in collaborating effectively with SOP process owners and authors. Learn to harness the synergy between documentation and training, elevating both SOP's and training quality.
Unearth the profound connection between SOP's, training curricula, and employee qualifications. This seminar goes beyond the basics, delving into technical writing, enforcing SOP's according to regulatory requirements and GDP, and SOPs for human error reduction. We'll demonstrate how to seamlessly integrate these critical elements into your training curricula, providing undeniable proof to internal auditors and regulatory bodies that your team is not just competent but excels in their roles.
Join SOP Synergy 2023 now where SOPs are not mere regulations but the backbone of your operational excellence. With four expert presenters leading the way, this seminar is your opportunity to chart a course toward industry-leading compliance, productivity, and success.
Agenda
Day 1
11.00 AM - 01.00 PM
- Relationship Between SOP's and Training Curricula - MICHAEL ESPOSITO
01.30 PM - 03.30 PM
- Technical Writing - Rules, Preparation and Process - CHARLES H. PAUL
Day 2
11.00 AM - 01.00 PM
- Enforcing SOP's as per Regulatory Requirements and GDP - KELLY THOMAS
01.30 PM - 03.30 PM
- Technical Writing - Rules, Preparation and Process - DR. GINETTE COLLAZO
Course Provider
Mr Michael Esposito,
Pharmaceutical Trainer ,
GMP TEAMichael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
Ginette Collazo,
Owner/Industrial/Organizational Psychologist ,
Ginette M. Collazo, LLC.Ginette Collazo , PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Charles H. Paul,
President ,
C. H. Paul Consulting, Inc.Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training
Who Should Attend
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Production Departments
- Compliance Departments
- Engineering Departments
- Research and Development Departments
- IT Departments
- Human Resources Departments
- Training and Development Departments
- Operations Departments
- Technical Services Management and Staff
- Documentation Departments
- Management - essentially everyone in the organization who is tasked with creating or reviewing procedures
