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      SOP Development and Implementation for the FDA-Regulated Industry in Revere


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      June 14, 2018

      Thursday   9:00 AM - 4:00 PM

      407 Squire Rd
      Revere, Massachusetts

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      EVENT DETAILS
      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
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