Two Day Writing and Enforcing Effective SOPs Seminar (Burlingame CA, United States - February 9-10, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Writing and Enforcing Effective SOPs" conference to their offering.

This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results.

Decide what business goals will be achieved through better management with SOPs and how those goals will be measured. The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. Following SOPs are much more important than writing them. Even the best written SOPs are useless if they are not followed.

SOPs are therefore the most popular documents audited by FDA and other Agencies, and certainly your auditors and customers. This session will provide insightful and useful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOPs. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs play in achieving the required level of compliance and quality.

Who Should Attend:

- Regulatory Affairs

- Clinical Affairs

- Quality Assurance/Quality Control

- Compliance

- Marketing & Sales

- Manufacturing and Technical Services

- Engineering

- IT/MIS

- Executive Management

- Laboratory Operations

- Customer Service

- Clinical Research managers and personnel

- Specialists/SMEs in all departments

- QA/RA managers and personnel

- Quality System auditors

- Distributors/Authorized Representatives

- Legal Counsel

- Consultants

Agenda:

Day 1 Schedule

Lecture 1: The SOP end user, required sections and best practices for SOP development

Lecture 2: Tips that help and work when you need to create, clear, concise procedures

Lecture 3: Improve your writing skills

Lecture 4: Development and formatting recommendations: Content and Structure

Lecture 5: Reminders that you need to know when you critique your own procedures

Lecture 6: FDA and overall global expectations and requirements for SOP development, implementation and enforcement

Lecture 7: Create SOPs for the target audience

Lecture 8: Provide appropriate level of details and use writing conventions

Lecture 9: Have increased confidence in planning and writing your SOPs

Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates

Day 2 Schedule

Lecture 1: Understand the full life cycle of SOPs

Lecture 2: Understand how training is integral to document approval

Lecture 3: Control, archival and disposal

Lecture 4: Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.

Lecture 5: Use various tools such as flowcharting to define a logical procedure

Lecture 6: Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message

Lecture 7: Ensure the document is written for the correct audience

Lecture 8: Link SOPs to good documentation practices

Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development

For more information about this conference visit http://www.researchandmarkets.com/research/7s9c6j/writing_and

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceutical Manufacturing