Writing Effective SOPs and Good Documentation Practices

Writing Effective SOPs and Good Documentation Practices Thurs. April 10th & Friday April 11th, 2014 BioCity Scotland, Bo’Ness Road Lanarkshire, ML1 5UH

Course

Writing Effective SOPs and Good Documentation Practices Date: Thursday 10th April, 2014 (9:15am – 4.45pm) and Friday April 11th, 2014 (9:00am – 4.30pm) Cost: £1095 (+VAT if applicable) A 10% discount will be given to the first 5 people to register

2 DAYs

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during GMP inspections and all too often they result in observations. This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOP’s that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality. The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises. Participants may bring an SOP related to their work for the workshop exercise on day two where individual questions will be addressed. Confidentiality will be respected.

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Writing Effective SOPs and Good Documentation Practices

Course Objectives and Content This course is designed to assist with writing effective SOPs which contribute to the overall compliance of a company. What regulatory inspectors look for in SOPs, Good Documentation Practices, Global Harmonization of SOPs and maintenance of the SOP system though change control are also discussed.           

Regulatory inspectors expectations for SOPs The role of SOP’s with respect to GMP operations, global harmonization, documentation and document control. Good Documentation Practices Reviewing current SOP’s to determine gaps and overlaps to strengthen the existing documentation system. Maintenance of SOPs Designing an SOP template to optimize efficiency of organization and formatting of SOP’s The team approach to SOP writing, defining responsibilities and knowing the audience. The importance of capturing the actual flow of an operation within the document Writing tips on how to keep the document concise, unambiguous and accurate. Training of SOP documents Managing revisions and deviations through a document Change Control System

This course will deliver the tools to enable you to: • • • •

Consider the impact of not following SOPs as written Understand the key role SOPs play in the overall quality and compliance system Use SOPs to improve the efficiency of operations Write user friendly documents which are easily followed and reflect current practices

Who Should Attend? This 2 day course is valuable for Managers, Supervisors, Laboratory Analysts, operators who are involved in the organization, writing or management of SOP’s required for GMP purposes in the Pharmaceutical and related industries with daily responsibilities in the following areas:

• • • • • • •

Quality Assurance Documentation Compliance Production Laboratory Regulatory Affairs Training

What’s included with the course? • • •

All participants will receive a certificate of attendance upon completion of the course. The participants will each receive a course manual and related printed materials Buffet Lunch and light refreshments will be served on both days.

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Writing Effective SOPs and Good Documentation Practices

Course Speaker Dr. Pauline McGregor, PMcG Consulting (bio on page 5)

Course Outline (Day 1 and Day 2) Questions and answers will be taken throughout the duration of the course. 8:45 am Registration and Coffee 9:15 am to 10:30am  Introduction - Exercise  Benefits of SOPs  Regulatory inspectors expectations for SOPs 10:30 am Morning refreshments 10:45 am to 12:15pm  The role of SOP’s with respect to GMP operations and Quality Systems  Global Harmonization  Good Documentation Practices 12: 15pm Lunch 1:30 pm to 3:00 pm  Maintenance of SOPs  Reviewing current SOP’s to determine gaps and overlaps to strengthen the existing documentation system.  Designing an SOP template 3:00 pm Afternoon refreshments 3:15 pm to 4.45pm

• Exercise • The Team Approach to SOP writing Day 2 9:00 am to 10:15 am  Defining Responsibilities and signatures  Ensuring the flow of the document for a consistent outcome  Exercise 10:15am Morning refreshments 10:30 am to 12:00 pm  Writing tips on how to keep the document concise, unambiguous and accurate 12:00 pm Lunch 1:00pm to 2.30pm  Training of SOPs  Exercise  The Change Control System 2:30pm. Afternoon Refreshments 2:45 pm to 4:30 pm  Managing Revisions  Recap  Individual SOP work 4:30pm Course Closes and Certificates 3 logo and background graphic by message-matters.com | +44 020 8207 6446

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Writing Effective SOPs and Good Documentation Practices

Venue Information BioCity Scotland, Bo'Ness Road, Newhouse, Lanarkshire, ML1 5UH www.biocity.co.uk

BioCity Scotland is located on the M8 just 40 mins from Edinburgh and 30 mins from Glasgow. There are train links from both Cities which are very frequent If arriving by air we recommend travelling to Edinburgh airport which is 25 minutes away although Glasgow airport is an alternative.

Junction 6 off the A8 motorway coming from Glasgow and Edinburgh Take the direction of Chapelhall Airdrie, Motherwell and Holytown Use the Post code ML1 5UH and ML1 5SH as some Sat Nav Systems will not recognise one postcode. Contact 01698 905120 for directions if you have any problems and we will be happy to assist.

Accommodation 1) Dakota Hotel – Eurocentral (recommended). Please quote BioCity Scotland to obtain a rate of £85 per night B & B (Based on single Occupancy) http://www.dakotahotels.co.uk/hotels/glasgow 2) Premier Inn - Newhouse http://www.premierinn.com/en/hotel/GLANEW/glasgow-motherwell Both hotels are a short Taxi ride from BioCity Scotland. Transportation by taxi to and from the hotel and BioCity Scotland will be provided free of charge for course attendees.

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Course Speaker Dr. Pauline McGregor, PMcG Consulting Twenty f i v e years in the p h a r m a c e u t i c a l i n d u s t r y has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK. Pauline completed her honours degree in Scotland on a part time basis while employed full time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering analytical R& D, method validation, GMP and related Quality Systems courses across Canada, in the US, the UK and China. She is a very highly rated presenter. Throughout her career, Pauline has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding. Pauline is also a member of The Royal Society of Chemistry, UK, listed on the RSC Directory of Consultants and is a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures.

PMcG Consulting Bridging the gap with expert training, education and communication At PMcG Consulting, our mission is to bridge the gap between different stages in pharmaceutical development, global practices, academia and industry, contract laboratories and pharmaceutical companies, through education, training and communication. We contribute to the pharmaceutical/biotech industry by means of training, problem solving and technical support, creating internal, external and global partnerships whilst assuring the highest level of quality.

In-HouseTraining PMcG provides training you’ll enjoy. Our courses are presented in a unique manner which includes group interaction and discussion, hands on exercises and case studies.

Documentation We can help prevent your documentation being the bottle neck of your operations and a cause of missed deadlines. Consistency, documentation and traceability are key factors in GMP compliance which protect the consumer and the company

Analytical Method and Technical Support Analytical method support is offered to laboratories and manufacturing sites to aid in problem solving of analytical methods relating to stability studies, formulation development and cleaning validation. Before a product can be tested, documentation that the laboratory is qualified to run the test must be available to the Regulatory authorities. Assistance is provided for the validation, transfer and verification of analytical procedures.

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Registration

REGISTRATION Register by Email: [email protected]

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 FEES INCLUDE:

Writing Effective SOPs and Good Documentation Practices £1095(+VAT if applicable)

Date: Thurs. 10th April, and Fri. April 11th, 2014 Cost: £1095 (+VAT if applicable)

Certificate Printed Manual Lunch Refreshments

A 10% discount will be given to the first 5 people to register Do you have any special dietary requirements? YES

If yes, please describe:

Method of Payment:

Cheque - Please make payable to Pauline McGregor and mail to: Attention of Pamela Farrell, c PM G Consulting, BioCity Scotland, Bo’Ness Road, Lanarkshire, ML1 5UH Direct Banking Payment – Please contact [email protected] for bank details

NOTE: Course fees must be paid prior to the course date or registrant will be denied admittance to the course. Upon receipt of payment, a proof of payment will be sent to you. PMcG Consulting reserves the right to modify the material or speakers, without notice or cancel the event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. PMcG Consulting cannot be responsible for discount airfare penalties, accommodation or other travel costs incurred due to a cancellation. Full refunds less a handling fee of £ 35.00 will be made for cancellations received in writing within 28 days of the commencement of the course. Refunds of 50% will be made for cancellations received in writing between 28 and 7 days prior to the commencement of the course. Regrettably no refunds can be made after 7 days prior to commencement of the course. Substitutions can be made at any time. If you fail to attend the course for which you’re registered, full course fees will be charged.

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