URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies,   Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training,   Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop,   Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training,   Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods,   Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s,   Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference,   Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program,   Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


CANCELLED: SOP Development and Implementation for the FDA-Regulated Industry


Date
Jun 15, 2021 - 09:00 AM
Organizer
GlobalCompliancePanel
Location
Four Points by Sheraton Boston Logan Airport Revere, MA,

Boston,
MA,
US,
ZIP: 10001
Phone:

SOP Development and Implementation for the FDA-Regulated Industry

 

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
JOA180521CEV

Event Categories
Keywords: fun, Clinical , communication , development , Fun , functions, implement, industry , Management , program




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