ComplianceOnline

This seminar will describe the requirements, the dos and don’ts commonly performed by laboratories, the writing of a Standard Operating Procedure (SOP), and ways to ensure that it is followed, up to date, and archived properly.

The SOP is one of the core elements within a compliant laboratory. Any action in the laboratory must be done by following an SOP, no matter how common or seemingly trivial the action might be. Under GLP or ISO 17025, the SOP must guide those doing the tasks in such detail that there are no chances of unacceptable variation, any chance of a non-compliance. This is a very high bar to meet.

A poorly written and followed SOP is one of the most common non-compliances that an auditor finds. If you are a laboratory worker, a supervisor, or manager of a laboratory seeking or under GLP or ISO 17025, you should know how to create and maintain a good SOP. Will your SOPs pass an audit or will they become a non-compliance corrective action?

An SOP is a meticulous step-by-step description of how to do a task that leaves no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specifics that are unique to that laboratory. Writing, implementing, maintaining, assessing, and revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. The individual roles will be described for each.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into a compliant SOP.

The necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP are complex and will be described. These include recordkeeping, safety, training, and other areas.

Learning Objectives:

Upon completing this course, participants should:

  • Know the roles within the laboratory of each individual in creating, implementing, monitoring, training, documenting, and updating an SOP.
  • Understand how the tasks in a methodology define the structure and detail in the SOP.
  • Understand the interrelationship of SOPs and how to incorporate those into a method SOP.
  • Know a cross-training approach to assess possible variation.
  • Know how to implement updates and when to changes are sufficient for a revalidated new version of the protocol.
  • Know the requirements and possible protocols for archiving.

Who will Benefit:

This course is aimed at those working in laboratories that must comply with Good Laboratory Practice or ISO 17025, especially those whose results are to be reported to the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA), and the US Occupational Safety and Health Administration (OSHA). The various roles:

  • Managers and supervisors of the laboratory
  • Quality officers and internal auditors
  • Scientists and research associates
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 9:00 am)
  • Session 1 (90 Mins)
    • What is the intention and role of SOPs?
    • What tasks require SOPs?
    • How the network of SOPs within the Lab support each other?
    • How is an SOP structured/ formatted?
  • Session 2 (90 Mins)
    • What are the compliance requirements for an SOP?
    • Descriptions of the roles and responsibilities of people in the SOP process.
  • Session 3 (90 Mins)
    • Description of the various standard methods.
    • The Regulatory Compliance Method.
    • The Scientific Published-Literature Method.
    • The Industrial Standard Method (ASTM and ISO methods).
    • How to assess if a standard method can be used as is as the SOP?
    • Conversion to an acceptable SOP from a standard method.
  • Session 4 (90 Mins)
    • How to create an SOP?
    • The SOP for a new task.
    • The SOP for a new methodology.
    • The SOP for a Standard method.
Day 02(8:30 AM - 4:30 PM)
  • Session 1 (90 Mins)
    • The Interplay within the lab to improve the draft SOP.
    • Reviewing the first attempt.
    • Iterations and how to assess the reaching of compliance.
  • Session 2 (90 Mins)
    • The Implementation of the SOP.
    • Training, The Documentation of Initial Training and the On-Going Proficiency testing as a Requirement.
  • Session 3 (90 Mins)
    • Monitoring and Assessing the SOP for Needs of Changes.
    • Modification, Updating, and Revising an SOP. When should an SOP be revised?
    • Revising the SOP and Its Documentation and Approval.
    • The Use of a Method Timeline to Track Changes.
  • Session 4 (90 Mins)
    • The Requirements in Archiving and Documentation.
    • Which SOP is to be used when?
    • Other requirements that must be included: Facility requirements, purchasing guidelines, safety issues methods of reporting (and standard forms and information to be reported).
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John C. Fetzer

John C. Fetzer, PhD,
Consultant, Fetzpahs Consulting

Dr. Fetzer has been a method-development analytical chemist for over 3 decades. In that role he developed new methods for GC, HPLC, fluorescence spectroscopy, titrimetry, the use of ion-selective electrodes, and physical properties of aqueous solubility and octanol-water partition coefficient that complied with Good Laboratory practices. As part of his consulting and contracting work he developed GLP-compliant methods for a biopharma startup and for a petrochemical company. In all of these various efforts, numerous SOPs were written, as well as the prototype of a later-approved ASTM method. He supervised and managed a GLP compliant laboratory for over 10 years and helped maintain the documentation necessary for compliance.

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$1,299.00

Seminar One Registration

February 7-8, 2018, Scottsdale, AZ
(For Registrations till October 25, 2017 - $1299)
(For Registrations till November 20, 2017 - $1499)
(For Registrations till December 20, 2017 - $1599)
(For Registrations after December 20, 2017 - $1699)

$5,999.00
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February 7-8, 2018, Scottsdale, AZ
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Your registration fee includes the workshop, all course materials and lunch.


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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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Location

Scottsdale, AZ
(Venue to be announced shortly)

February 7-8, 2018

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Scottsdale, AZ

Phoenix Skyline

Phoenix Skyline

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METRO Light Rail Transportation

METRO Light Rail Transportation

METRO is now open and operating with traffic in the cities of Phoenix, Tempe and Mesa. At any time of the day or night, you can find yourself near an operating light rail vehicle or a METRO train consisting of two or three vehicles connected together.

MLB Spring Training

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The Cactus League has been an Arizona tradition for over a half-century. What began as a two-team league in 1947 has grown to twelve Major League Baseball teams playing in seven cities throughout the state. The league's popularity is at an all-time high with games scheduled every day in March. The Cactus League offers baseball enthusiasts an excellent opportunity to enjoy their favorite teams in fan-friendly, state-of-the-art ballparks.

Arizona Sunset

Arizona Sunset

Be sure to bring your camera as the desert offers spectacular sunsets and beautiful scenery year round.

Red Rocks

Red Rocks

Red Rock State Park in Sedona (110 miles) is an open-sky theatre of fabulous rock formations. Sprawled across 286 unspoiled acres, this popular park is the perfect starting point for hiking, picnicking, bird watching and photography.

Cathedral Rock

Cathedral Rock

Cathedral Rock in Sedona is 110 miles away and offers a great hiking trail for the adventurous. Cathedral Rock, also known as 'Lovers', was thought to be created by the Great Spirit. A couple of lovers, who always argued, were asked by Him to look around at the beautiful surroundings and count their blessings. The couple was believed to never argue thereafter and stands in perfect harmony.

Camelback Mountain

Camelback Mountain

Camelback Mountain draws thousands of visitors with its sheer red sandstone cliffs and its telltale hump. Hiking to the top is not for beginning hikers -- the two summit trails are strenuous climbs over sometimes-tricky trails. Some easier trails allow close-up exploration around Camelback's base.

Montezuma Castle

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Located 90 miles north of Phoenix, you can marvel at the 1,000 year old legacy of the Sinagua as you explore the ruins at Montezuma Castle National Monument. A paved, 1/3 mile loop trail takes you through a tranquil sycamore glade and past the ancient cliff dwellings of a people surprisingly similar to us.

Prickly Pear Cactus

Prickly Pear Cactus

Prickly pear cactus are found in all of the deserts of the American Southwest, and are abundant in the mountains around Tucson and offer a beautiful site when they flower in the spring.

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