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Seminar on Writing and Enforcing Effective SOPs

 
  December 01, 2016  
     
 
NetZealous DBA as GlobalCompliancePanel, SFO, CA
09-02-2017


Overview:

Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.

Who will benefit:

This Seminar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology manufacturers and other firms in the life sciences industry who require a refresher session on writing and enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better understanding of the SOP process. The employees who will benefit include basically anyone and everyone at your organization who are required to write and/or comply with SOPs, including all levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP process from start to finish, including:

  • 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

Location: SFO, CA Date: February 9th & 10th, 2017and Time: 9:00 AM to 6:00 PM

 

Venue: DoubleTree by Hilton Hotel San Francisco Airport

Address: 835 Airport Blvd., Burlingame CA 94010-9949

 

 

Price:

 

Price: $1,295.00 (Seminar Fee for One Delegate – Without Stay)

 

Until January 10, Early Bird Price: $1,295.00 from January 11 to February 7, Regular Price: $1,495.00

 

Register for 5 attendees (With stay)   Includes   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register now and save $200. (Early Bird)

  

 
 
Organized by: NetZealous LLC - GlobalCompliancePanel
Invited Speakers:

David R. Dills,

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

 

 
Deadline for Abstracts: 07/02/2017
 
Registration:

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR 

E-mail: support@globalcompliancepanel.com
 
   
 
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