Global Quality Standards – the new approach to compliance documentation
OVERVIEW
Standard Operating
Procedures and work instructions – the compliance documentation required by
regulation – are essential to the effective and compliant running of any
regulated business. Unfortunately, many individuals in those businesses miss
the valuable opportunities that properly developed Standard Operating
Procedures/Work Instructions can provide. Regulated documentation can
serve a variety of purposes other than meeting a regulatory requirement – as
training materials, to standardize operations, to manage individual and group
performance, to identify the sources of deviations, etc. The key is to
knowing how to write standard operating procedures and work instructions to
properly meet those needs.
The approach and
philosophy here are new to the industry and focus on achieving maximum benefit
of compliance documentation across many applications to achieve both
operational efficiencies and compliance excellence. This webinar will
address the new thinking as to how documentation hierarchies should be organized
to reflect a global focus on how your documentation should be structured.
This webinar will also
discuss how to transform your regulatory documentation process a profit center,
an operational force multiplier in how you run your business, and an effective
central focus of your technical training function
WHY
SHOULD YOU ATTEND
Writing effective
Standard Operating Procedures and Work Instructions is not intuitive, it is not
a skill that is often taught in our universities, and it can be a difficult and
cumbersome task to execute. Knowing the most effective and efficient processes
for gathering, organizing, and writing technical documentation is absolutely
critical to providing significant value to a dreaded, avoided, and seemingly
(and wrongfully) unimportant work task.
AREAS
COVERED
- Define the
true purpose and function of regulatory documentation.
- Determine
the value add that regulatory documentation can bring to your
organization.
- Identify
the pitfalls associated with writing regulated documentation.
- Explain
the purpose and function of a documentation hierarchy – and the new global
thinking concerning documentation hierarchies.
- Explain
how documentation is created.
- Identify
and explain the best types of formats that can used to develop standard
operating procedures and work instructions
- Explain
the best techniques for gathering the technical information you need to
develop your documents.
- Explain
how to most effectively work with Subject Matter Experts.
- Explain
how to streamline regulatory document management system and manage
technical document reviews
LEARNING
OBJECTIVES
- Compliance
documentation should never be developed to simply meet a regulatory
requirement.
- Compliance
documents, properly crafted, can significantly minimize the training
burden faced by life sciences companies today.
- Compliance
documents, properly crafted, can virtually eliminate the potential for
deviations throughout the operation.
- Compliance
documentation, properly crafted, is a valuable performance management tool
for both managers and associates alike.
WHO
WILL BENEFIT
Anyone tasked with the
development of regulatory documentation in any regulated industry - the
Life Sciences (medical devices, pharmaceuticals, biologics, etc), foods,
cosmetics, beverages, nutraceuticals, etc.
This webinar has a
very broad base from which to solicit participants. Virtually any
regulated industry as previously defined and virtually any job classification
level – associates through managers and in virtually any organizational
function – operations, facilities, logistics, purchasing, laboratory, research
and development, engineering, maintenance, etc.
For more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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