SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

from Referral

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.
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.

Learning Objectives:
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 Will Benefit:
This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance:
Regulatory operations
Clinical investigators, site management and contracting personnel
Clinical operations
Project managers
Data management
Medical writers
Compliance officers

Note: Use coupon code REFERRAL10 and get 10% off on registration. (from )

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