SOP Development and Implementation for the FDA-Regulated Industry

 Course "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. Overview: 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. Why should you attend: One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. Areas Covered in the Session: • Regulatory requirements for GCP SOPs • Regulatory requirements for GMP SOPs • Legal requirements for SOP creation and maintenance • Types of SOPs • Formats and essential components of SOPs • How to effectively write an SOP to ensure compliance • SOP training and implementation • Deviations from and changes to SOPs Who Will Benefit: • Directors • Managers • Supervisors • Auditors • Regulatory operations • Clinical investigators, site management and contracting personnel • Clinical operations • Project managers • Data management • Medical writers • Compliance officers Agenda: Day 1 Schedule ________________________________________ Lecture 1: (9:00-9:30) Introductions ________________________________________ Lecture 2: (9:30-10:30) Legal requirements for SOP creation and maintenance Types of SOPs Regulatory requirements for GMP SOPs ________________________________________ 10:30-10:45 Break ________________________________________ Lecture 3: (10:45-12:00) Regulatory requirements for GMP SOPs, continued DISCUSSION: Phasing in SOPs to be consistent with phase of development. ________________________________________ 12:00-1:00 Lunch ________________________________________ Lecture 4: (1:00-2:30) Regulatory requirements for GCP SOPs ACTIVITY: Prepare an SOP to ensure consistent success in an operation ________________________________________ 2:30-3:00 Break ________________________________________ Lecture 5: (3:00-4:00) ACTIVITY: Conduct SOP training on prepared SOP ACTIVITY: Implement prepared SOP DISCUSSION OF ACTIVITY OUTCOME DOCUMENTING LEARNINGS FROM DAY 1 ________________________________________ 4:00 End of Day 1 Day 2 Schedule ________________________________________ Lecture 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 How to effectively write an SOP to ensure compliance DISCUSSION: SOP effectiveness based on Day 1 Activity ________________________________________ 10:30-10:45 Break ________________________________________ Lecture 3: (10:45-12:00) SOP training and implementation DISCUSSION: The most effective training techniques ________________________________________ 12:00-1:00 Lunch ________________________________________ Lecture 4: (1:00-2:15) Deviations from and changes to SOPs ACTIVITY: Documenting and assessing deviations & changes to an SOP ________________________________________ 2:15-2:30 Break ________________________________________ Lecture 5: (2:30-3:00) DISCUSSION OF ACTIVITY DOCUMENTING LEARNINGS FROM DAY 2 EVALUATIONS ________________________________________ 3:00 End of Program Speaker Peggy Berry President & CEO, Synergy Consulting Peggy 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). Location: Boston, MA Date: June 14th & 15th, 2018 and Time: 9:00 AM to 6:00 PM Venue: Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States Price: Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until May 10, Early Bird Price: $1,295.00 From May 11 to June 12, Regular Price: $1,495.00 Sponsorship Program benefits for “Biostatistics for Non-Statistician” seminar For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! 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