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Aug 18


SOP WRITING, TRAINING AND COMPLIANCE IN THE PHARMACEUTICAL INDUSTRY

Part of the Pharma & Medical Device Topics collection
by Comply Rules
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$899


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$899
Tickets


DATE AND TIME

Thu, Aug 18, 2022, 1:00 PM –

Fri, Aug 19, 2022, 5:00 PM EDT


LOCATION

Online event


REFUND POLICY

2-Day Virtual Seminar SOP Writing, Training, and Compliance in the
Pharmaceutical Industry.


ABOUT THIS EVENT

About this event:

Date: Aug 18-19, 2022.

Time: 1 PM ET - 5 PM ET

Duration: 2 Day 8Hrs 4Hrs/Day.

Level: Intermediate to Advanced

Group Packages: Please contact ben@complyrules.com

Standard Operating Procedures (SOPs) are the basis for a large part of the
day-to-day training that most pharmaceutical employees are required to perform.
Still, it is not widely understood the extent of the commitments we make when we
write an SOP or how the writing of the SOP can have a positive or negative
impact on training or job performance. For example, there is an expectation that
procedures describe the most critical processes for product manufacturing and
will be followed consistently, with few if any deviations. In this course you
will learn the keys to writing effective SOPs, the vital connection between the
documentation and training spheres, and how to maximize this connection to
improve the quality of both SOPs and training.



To accomplish these goals, we will review regulatory agency expectations when an
SOP is written, provide suggestions for uncovering the process in its entirety
and describe it clearly and concisely, indicate how to break portions of the
process(es) into logical chunks, and show how the SOP and the training program
can work together harmoniously.



Understanding how the average employee is swamped with more work than they can
manage, we will also provide tips for shortening this process and take advantage
of tools that probably already exist in the systems that you use on a day-to-day
basis. We will provide valuable insights and examples that reflect the extensive
experience of the instructor in the documentation and training fields., and
which can assist you in writing and implementing SOPs with maximum efficiency
and effectiveness.

Learning Objectives:



 * To improve the writing of SOPs for more effective training and reduction of
   errors.
 * To understand the regulatory implications of what is written in an SOP
 * To learn the parameters of an effective SOP
 * To distinguish a well-written SOP from a poorly written one
 * To define processes better by effective interaction with the SOP process
   owner and/or author
 * To integrate the SOP effectively into the position curricula of employees
 * To explore the connection between SOPs and job performance, and measure
   retention of SOP content at the training stage

Areas Covered :



 * Regulatory requirements for SOPs
 * Using process excellence tools to create a robust process and procedure
 * What commitments you make when you put your process in writing
 * Keeping training in mind while writing procedures
 * Consequences of noncompliance
 * Define the parameters of an effective SOP
 * How your foundation keeps subsequent steps from going awry
 * Why poorly written procedures have a negative impact on production
 * What identifies a poorly written procedure
 * Compliance risks with ambiguity or excessive detail
 * Interact with the SOP process owner/author to improve the writing of
   procedures
 * Integrate the SOP effectively into the position curricula of employees
 * Relationship between SOPs and employees’ training curricula
 * Why the training department needs to be in the loop at the start of the SOP
   development process
 * Retention of the content at the training stage
 * The implications of good training for successful SOP execution
 * Perform an ongoing assessment of knowledge retention of SOPs for continuous
   improvement
 * Review of learning objectives

Who will Benefit:

Pharmaceutical industry, particularly those areas that develop SOPs for the
manufacturing or quality monitoring of pharmaceutical products, as well as
Information Technology (IT)

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially
tailored as per the client's requirement. We arrange calls between clients and
our course instructors to better understand the training requirement and
accordingly a training program is designed. The course duration ranges between
90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3
days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own
specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA
Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation,
Clinical compliance, and almost everything that falls under Risk, Quality and
Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in
Risk management and Regulatory compliance then let me know and we can design a
highly cost efficient program for you.


TAGS

 * Online Events
 * Online Classes
 * Online Business Classes


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COMPLY RULES

Organizer of SOP Writing, Training and Compliance in the Pharmaceutical Industry



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