SOP Development and Implementation for the FDA-Regulated Industry Global Compliance Panel
Delivery Method
Seminar
Target Audience Directors, Managers, Supervisors, Auditors, Regulatory operations, Clinical investigators, site management and contracting personnel, Clinical operations, Project managers, Data management, Medical writers, Compliance officers
Summary 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.
Description/Agenda
Overview:
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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).
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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