Writing and enforcing effective so ps

Description:
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.
1/24/2017 www.grcts.com 2

The goal and emphasis with FDA is simple. Proof of "Establish" is the
foundation. Is the firm doing what the regulations specify? Is the firm doing
what their procedures specify? Are the procedures being followed and
enforced by company personnel? SOPs are needed in regulated industries
to give step-by-step instructions for performing a particular job or task.
This session will provide a step-by-step overview and a snapshot of the
procedure description, the process and format. The subject matter of a SOP
may range from how to operate a piece of machinery to how to log into a
particular software program. SOPs ensure consistency and reliability
because they require training of all affected parties.

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.

Areas covered in the session:
 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

Who will benefit :
This webinar 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:

Inside Job: The Growing Internal Cyber-Threats and How to Protect Against
Them
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

Instructor Profile :
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently
provides regulatory affairs, compliance and quality consultative services
for early-stage and established Class I/II/III device, In Vitro Diagnostics,
cosmetics and bio/pharmaceutical manufacturers on the global landscape,
and also has an accomplished record with more than 25 years of
experience in the areas of Regulatory Affairs, Compliance and Quality
Systems. He has been previously employed, with increasing
responsibilities by medical device manufacturers and consultancies,
including a globally recognized CRO and has worked directly with
manufacturers engaged in compliance remediation activities and services
involving consent decrees, CIA’s, warning letters, 483 observations, and
customer generated compliance events, and prepares for and conducts QS
and regulatory audits.

He has been directly involved with constructing, reviewing, and/ or
remediating regulatory submissions, including 510(k), PMA, IDE
applications, IND, BLA and NDA submissions, preparing Supplements,
Amendments, U.S. Agent, works closely with the key stakeholders and
Agency/Center Reviewers regarding submission meetings and negotiations;
clinical affairs and study submissions; and provides regulatory submissions
and post-market project leadership and guidance covering different
therapeutic and medical specialties based on classification.

Mr. Dills has a strong background in the interpretation and applicability of FDA
regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation
and compliance requirements, GxP training, leads and directs activities for the
registration and approval process and working with Agencies in Asia Pacific, EU and
The Americas, including but not limited to FDA, European Medicines Agency–EMA,
MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and
executing regulatory compliance, risk mitigation and remediation strategies in
response to inspection findings. Additional activities include Pre-FDA Facility
Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-
approval inspection (PAI/PMA), proof of management oversight, facilitate and direct
efforts for remediation planning and monitoring, and assessment of the critical sub-
systems, records and document controls; and strives for reduction of regulatory
compliance risk for companies.

Directs and leads efforts for PM support and consultative services on behalf of
manufacturers and subcontracted by third-party consultancies and provides services
involving all phases of the product development, submission, and commercialization
process from premarketing to postmarketing; retained as U.S. Agent for international
pharma and device clients; conducting supplier and QS audits/assessments;
establishment registration and listing; Agency inspection readiness preparation and
remediation; preparing Agency responses due to enforcement actions; conducting
GxP audits and preparing CAP/remediation plans; compliance engineering support;
support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting,
Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or
remediate Quality Management and documentation systems for GxP compliance;
preparation for ISO 13485 registration and CE Mark; and multi-country product
registrations and licensing.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing
priorities having a direct impact on site operations/commercial opportunities. Develops
strategies for governmental approval to introduce new products to market, provides
guidance and clarity on regulatory requirements, prepares and/or reviews submissions
[e.g., NDA, ANDA, 510(k), PMA, IDE and BLA], including design dossiers and technical
files, and other applications for Asia Pacific, The Americas and EU. Directs and leads
efforts in establishing and retooling QA systems with emphasis on preventing the
design, manufacture, and shipment of defective product; provide compliance
engineering support; and lead efforts for GxP Strategic Compliance.

Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and
complaints) related to development, manufacturing, and commercialization, and
recommends action to senior leadership to ensure effective resolution for
manufacturers to achieve sustainable and proven compliant systems. Background
encompasses broad capabilities in quality systems; documentation development and
remediation; RA/RC oversight and governance; design controls;
CAPA/investigations; GxP training; software and process validation with compliance
oversight; supplier management; interfaces with FDA and other Agencies on the
regulatory landscape; compliance with MDD/IVDD Directives and Technical
File/Design Dossier and CE Mark requirements; and demonstrates credible
experience to optimize business performance through proactive strategies to
mitigate compliance exposure.

He also develops strategies and adds business value to manufacturers by
providing strategic and tactical solutions that facilitate the achievement of
regulatory and quality milestones and on minimizing delays due to
noncompliance. He conducts Compliance Governance Assessments and
Agency Mock Inspections; provides assistance during inspections and with
post-inspection correspondence and meetings, involved in the product life
cycle and commercialization process and works effectively across all
functions for overall corporate compliance to support a company’s goals
and strategies.

Mr. Dills analyzes the benefits/risks for informed decision-making;
interprets the regulatory precedents and new legislation; understands the
competitive landscape; develops the business and regulatory approach;
conducts persuasive communication with regulatory authorities; executes
an effective path to approval; assists with GxP compliance strategies,
effectively coordinates development in multiple markets; selects
appropriate testing and manufacturing suppliers; and strives for overall
corporate compliance with regulations in The Americas, EU, and Asia
Pacific.

He provides direction on understanding the regulatory landscape for the
product and provides a fully integrated approach to device development
including design controls, and effective communications with Regulatory
Authorities related to product development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical
Training Institute, Editorial Advisory Boards for Software Quality
Professional and the Institute of Validation Technology (IVT), publisher of the
Journal of GXP Compliance and Journal of Validation Technology and on the
Readers’ Board for Medical Device & Diagnostic Industry and Medical
Product Manufacturing News and was nominated and accepted for inclusion
into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and
compliance-related articles, commentaries and technical guides, and
is an accomplished global industry presenter. Mr. Dills’ academic
degrees include Environmental Science and Biology. He is a former
Chair and Co- Chair of ASQ’s Section 1506 and associated with the
Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry
working groups

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