5 Significant Training courses on 'SOP' Management

SOP (Standard Operating Procedure), is used in a variety of different contexts, including healthcare, aviation, engineering, education, clinical research and many more. This webinar series will edify you in creation, management and implementation of adequate SOPs according to FDA criterions.
Instructor: Mukesh Kumar, Chitra Edwin, David R Dills, Angela Bazigos
Product ID: PACK70007

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

QA/QC/Compliance/Regulatory Professionals | Senior Management Executives (CEO, COO, CFO, etc) | Manufacturing/Project Managers, Supervisors and Personnel | Clinical and Preclinical Laboratory Managers | Clinical Research Associates and Supervisors | Clinical Trial Specialists | Project Managers | Data Managers | Principal Investigators | Sponsors of INDs | GLP, cGMP, GxP and GCP Managers, Supervisors | Marketing & Sales | IT/MIS | Legal Counsel


Webinars included in the Package:

10 Steps to Perfect SOPs: FDA Compliance made easy (Duration: 60 Minutes)

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.

Objectives of the Presentation:

  • Essential elements of an SOP
  • Process mapping techniques to define the contents of an SOP
  • Role of personnel in creating SOPs
  • SOP revisions, updates, creation, retirement and documentation
  • Categorization of SOPs
  • Assessment of compliance techniques
  • Training practices for FDA compliance
  • Access and access control to SOPs

Instructor Profile:

Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.


Quality SOPs: Guidelines to developing and writing FDA Compliant Documents (Duration: 75 Minutes)

Clearly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization. SOP reviews are a high priority with auditors during an inspection. Poor quality, incomplete or non-existent SOPs are frequently a definite cause of a failed inspection.

Objectives of the Presentation:

Poorly crafted and incomplete Standard Operating Procedures (SOPs) are the nemesis resulting in FDA 483 observations and Warning Letter citations. Implementing an organized SOP system will ensure that these deficiencies are eliminated. Adequate training and communication within an organization with all levels of personnel will enforce complaint documentation of procedural details necessary to generate accurate and reproducible results. Instilling the importance of accuracy and attention to detail during training sessions will be a motivator for personnel to adhere to approved SOPs while fulfilling their routine responsibilities that are impacted by regulatory compliance.

Instructor Profile:

Chitra Edwin, Ph.D., RAC. has significant product development and management experience in start-ups, mid-sized and large biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been a key member in the development of products for AIDS and cancer that have obtained regulatory approval.


Writing and Enforcing Effective SOPs (Duration: 60 Minutes)

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."

Objectives of the Presentation:

  • The SOP end user, required sections and best practices for SOP development
  • Tips that help and work when you need to create, clear, concise procedures
  • Improve your writing skills
  • Development and formatting recommendations: Content and Structure
  • Reminders that you need to know when you critique your own procedures
  • FDA and overall global expectations and requirements for SOP development, implementation and enforcement
  • Create SOPs for the target audience
  • Provide appropriate level of details and use writing conventions
  • Have increased confidence in planning and writing your SOPs
  • Understand the industry standards for procedure writing, including typical components of documents, and using document templates
  • Understand the full life cycle of SOPs
  • Understand how training is integral to document approval
  • Control, archival and disposal
  • Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures
  • Use various tools such as flowcharting to define a logical procedure
  • Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
  • Ensure the document is written for the correct audience
  • Link SOPs to good documentation practices
  • Define clear responsibilities, roles and goals for personnel involved in SOP development

Instructor Profile:

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for medical device, pharmaceutical and biotech manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.


Critical SOPs for Clinical Sites (Duration: 60 Minutes)

Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.

Areas Covered in the Webinar:

  • Current FDA expectation from clinical sites
  • List of key SOPs critical to demonstrate GCP compliance
  • Best practices related to SOP development and maintenance by clinical sites
  • Current industry practices for SOPs
  • Common issues with FDA audit for site processes.

Instructor Profile:

Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.


Writing Effective SOP’s (Duration: 90 Minutes)

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Areas Covered in the Webinar:

  • SOPs and their relation to the regulations
  • SOPs as part of the company's regulatory infrastructure
  • SOP on SOPs and how to ensure conciseness, consistency and ease of use
  • Risk Based approach on SOP Best Practices for creation and maintenance
  • Training on SOPs
  • Tools for SOP tracking and when is validation required
  • What the FDA looks for in SOPs during an inspection

Instructor Profile:

Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

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