SOP Development and Implementation for the FDA-Regulated Industry Seminar
Presented by Global Compliance Panel
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Course DescriptionOverview:
Agenda: Day 1 ScheduleLecture 1: (9:00-9:30) Introductions Lecture 2: (9:30-10:30) Legal requirements for SOP creation and maintenance 10:30-10:45 Break Lecture 3: (10:45-12:00) Regulatory requirements for GMP SOPs, continued 12:00-1:00 Lunch Lecture 4: (1:00-2:30) Regulatory requirements for GCP SOPs 2:30-3:00 Break Lecture 5: (3:00-4:00) ACTIVITY: Conduct SOP training on prepared SOP 4:00 End of Day 1 Day 2 ScheduleLecture 1: (9:00-9:30) Review of Day 1; Questions from Day 1 Lecture 2: (9:30-10:30) Formats and essential components of SOPs 10:30-10:45 Break Lecture 3: (10:45-12:00) SOP training and implementation 12:00-1:00 Lunch Lecture 4: (1:00-2:15) Deviations from and changes to SOPs 2:15-2:30 Break Lecture 5: (2:30-3:00) DISCUSSION OF ACTIVITY 3:00 End of Program
Speaker:
Peggy BerryPresident & CEO, Synergy ConsultingPeggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of "Choosing the Right Regulatory Career" (RAPS, MD 2010) and author of "Communication & Negotiation" (RAPS, MD 2011). Credits AvailableCourse "SOP Development and Implementation for the FDA-Regulated Industry " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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