E: registration@peganix.com

T: +2711 041 0181

F: +2786 407 8243

M: +2761 490 3225

This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or workingunder Good Laboratory Practice regulation for the first time.

The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulationsfor facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems. Theresponsibilities and functions of management including the Study Director, Principal Investigator and the QualityAssurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will bepresented.

Emphasis will be placed on the practical implementation of GLP and discussion including problems that the participantsbring to the course.

▪ Sound regulatory basis for quality assurance activities

▪ Clear understanding of the role of Quality Assurance, Manage-

ment and Study Director under the Good Laboratory Practice

principles

▪ Improved inspections and audits

▪ Improved Good Laboratory Practice compliance for your facility

▪ An insight into government GLP monitoring activities

▪ Discuss and develop ideas▪ Solve specific problems▪ Examine particular aspects of

GLP

E: registration@peganix.com T: +2711 041 0181 F: +27 86 604 1175

▪ ScientistsRegulatory/Compliance Personnel

▪ Quality Assurance Staff

▪ Those newly assigned GLP responsibilities

▪ More experienced personnel needing to update theirknowledge

E: registration@peganix.com T: +2711 041 0181 F: +27 86 604 1175

RegistrationWelcome and Introduction

Good Laboratory Practice Standards andRegulationsAn insight into the background and history of GoodLaboratory Practice:

Principles of Quality Assurance (1)The role and responsibilities of QA:

Principles of Quality Assurance (2)The role and responsibilities of QA:

Study PlansGLP requirements and QA involvement:

Standard Operating ProceduresGLP requirements and QA involvement:

InspectionsAttitudes, techniques and attributes:

Workshop 1 – Facility and Process InspectionsAn exercise in inspection planning and preparation forinspections:

Workshop 1 – Continued Workshop 1– Feedback

An opportunity for delegates to put questions to thepanel of speakers:

Workshop 2 – A Mock Audit

Workshop 2 – Feedback

Auditing the Study ReportTechniques and methods for the QA audit of the studyreport:

The Management of Raw Data, Record Keepingand Training Records (1)

● The impact of GLP on data and recordsmanagement

● The use of computers in a GLP environment

The Management of Raw Data, Record Keepingand Training Records (2)

Workshop 3 – Amendments to Study Plan andDeviations from the Plan

● What are they?● What is the difference between them?● How are they controlled?

Workshop 3 – Feedback

Regulatory ComplianceGovernment monitoring for compliance with GoodLaboratory Practice:

An opportunity for delegates to put questions to thepanel of speakers:

Register or Enquire1 Tel : (+27) 11 041 01812 Fax : (+27) 86 407 82433 Email : registration@peganix.com4 Web : www.thailand.peganix.com / www.peganix.com5 Post : PO Box 1042, Ferndale 2160. Johannesburg, South Africa

RESEARCH QUALITY ASSURANCE FOR GOOD LABORATORY PRACTICE (GLP)

EmailPositionTitle Delegate Name & Surname

Delegate Attendance information:Note: Please provide information as you wish it to appear on your name badge and on the official participant database.

Please register the following delegate(s) for the eventI would like to claim my group discountI would like to claim a 10% discount as a member of: _______________________________________________________I would like to claim a 50% discount as a registered and existing subscriber of Peganix (pty) LtdI would like to use my credit.We would like this as an In-House - Dates: ____________________

Approving Manager

Billing Information / Account Manager

Job Title & Department : Email : Direct Tel :

Full Company Name : Nature of Business :

Address :

First Name : Surname :

Fax : Country: Postal Address:

Signature: Date:

First Name : Surname :

Contact Sean via:

Registration Form:

1. Only corporate registrations will be accepted.

2. Group Discount: Groups of 5 or more from the same company (booking at the same time and of thesame billing source) can enjoy a10% off the total delegate feesor have the 6th delegate comefor free.

3. Super Early Bird & Early Bird Promotion: Early Bird Fees will only be valid if payment is received bystipulated date, after which Regular Fee will apply.

4. Full payment is mandatory upon registration for admission to the event.

5. Fee includes lunch, refreshments and documentation.

6. The organiser reserves the right to make any amendments that it deems to be in the interests of the eventwithout any notice.

Important Notes

A replacement is welcome if you are unable to attend. A full refund less 10% administrat ive charge will be made for cancellationreceived in writ ing 2 weeks before the event. Regrettably, no refund can be made for c ancellation received after 2 weeksbefore or for “ no show” particip ant. You will how ever be credited to a future Peganix event. This credit will be available forup to one year from the date of issuance. In the event that Peganix postpones an event, delegate payments at the postponementdate will be credited towards the rescheduled date. If the delegate is unable to attend the rescheduled event, the delegatewill receive a credit voucher representing payments made towards a future Peganix event. No refunds will be available forcancellations or postponements. Peganix is not responsible for any loss or damage as a result of a substitution, alteration orcancellation/postponement of an event. Peganix shall assume no liability whatsoever in the event this conference is cancelled,rescheduled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performanceof this event impracticable or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to:war, fire, labour strike, extreme weather or other emergency. Please note that speakers and topics were confirmed at thetime of publishing, however, circumstances beyond the control of the organisers may necessitate substitutions, alterations orcancellations of the speakers and/or topics. As such,Peganix reserves the right to alter the advertised speakers and/or topicsif necessary. Any substitutions or alterations will be updated on our web page as soon as possible.

Cancellations & Replacements

Hotel room reservation and hotel billing are to be made by delegate directly with theHotel. Hotel reservationand travel arrangements are the responsibility of the registrant.

Workshop Venue & Hotel Reservation

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TERMS & CONDITIONS

By signing and returning the registration form, the authorising signatory on behalf of the statedcompany is subject to the following Terms & Conditions:Delegate Substitutions – Delegate substitutions are welcome at any time and do not incur anyadditional charges. Please notify Peganix in writing of any changes.Delegate Cancellations – All delegate cancellations must be received in writing and are subject to thefollowing conditions:▪ for any cancellations received 2 weeks before the start of a training course, will issue a creditvoucher for the value paid to be used for up to one year for current events from the date of issuefor any future training.▪ for any cancellations received less than 2 weeks before the date of the training course, the fullfee will be payable and no refunds or credit vouchers will be given▪ if a registered delegate does not cancel and fails to attend the training course, this will be treatedas a cancellation and no refund or voucher will be issuedTransfers; Transfer requests must be made in writing 7 days before the start of the eventPeganix▪ Please note that speakers and topics were confirmed at the time of publishing, however,circumstances beyond the control of the organizers may necessitate substitutions, alterations orcancellations of the speakers and/or topics.▪ As such, Peganix. Reserves the right to alter the advertised speakers and/or topics if necessary.Any substitutions or alterations will be updated on our web site as soon as possible

Payment Policy

Payment - In order to secure your registration, payment is due in full upon receipt of invoice.Confirmation - Your registration will not be confirmed until such time as payment is received and may be subject tocancellation.Right of Admission - Peganix reserves the right to refuse admission to the training course where evidence of fullpayment cannot be shown.In-House - Full payment is to be made to Peganix before running an In-house Training

Payment Methods

Electronic Transfer Direct Deposit Draft Cheque

Bank: First National BankAccount name: Peganix (Pty) LtdAccount no.: 62453975701Branch code: 250 655Swift code: FIRNZAJJReference: Insert your ref number on the deposit slip please

Banking Details

Number of stuff your company/organisation is delegating to the event?

28 - 29 September 2017 - InterContinental Bangkok. Thailand

2-Day Course

Early Bird Discount

USD1, 800.00*

2-Day Course

Course Fees

USD2, 000.00*Register before 25 August 2017