PRN: Two Day SOPs for FDA-Regulated Industry Workshop: Best Practices to Withstand FDA Expectations - Boston, MA, United States - June 15-16, 2017 - Research and Markets

29/mar/2017 12:15:42 PR Newswire Turismo Contatta l'autore

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Two Day SOPs for FDA-Regulated Industry Workshop: Best Practices to Withstand FDA Expectations - Boston, MA, United States - June 15-16, 2017 - Research and Markets

 
[29-March-2017]
 

DUBLIN, Mar 29, 2017 /PRNewswire/ --

Research and Markets has announced the addition of the "SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations: 2-day In-person Seminar" conference to their offering.

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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.

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.


Learning Objective:

- Regulatory requirements for 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 Should Attend:

- Directors
- Managers
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control personnel
- Auditors
- Clinical investigators, site management and contracting personnel
- Clinical trial specialists
- Project managers
- People investing in FDA-regulated product development projects

Agenda:

Day 01 (8:30 AM - 3:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

9:00 - 10:00 - Overview of SOPs

10:00 - 10:15 - Break

10:15 - 12:00 - SOP structure and creation

12:00 - 12:45 - Lunch

12:45 - 2:15 - What SOPs need to be created

2:15 - 2:30 - Break

2:30 - 3:30 - Writing an SOP

3:30 - 4:30 - Review of Inspection-cited deficiencies

Day 02 (8:30 AM - 3:30 PM)

8:30 - 10:00 - Standard SOPs required for Key Drug Development Processes

10:00 - 10:15 - Break

10:15 - 12:00 - Outsourcing activities

12:00 - 12:45 - Lunch

12:45 - 2:15 - Preparing the SOP

2:15 - 2:30 - Break

2:30 - 3:30 - SOP Communication and Training

3:30 - 4:30 - Preparing for Audits and Inspections

For more information about this conference visit http://www.researchandmarkets.com/research/qsszm8/sops_for


Media Contact:


Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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